The Daily Biotech Pulse: Allogene Sinks On FDA Clinical Hold, Takeda Gets Adcom Backing, Quidel Reports Q3 COVID Revenues, IPOs

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Oct. 7)

• Alkermes plc ALKS
• Bicycle Therapeutics plc BCYC (announced interim Phase 1 data for BT5528 and preliminary results from Phase 1 study of BT8009)
• Catalyst Pharmaceuticals, Inc. CPRX
• Cytokinetics, Incorporated CYTK
• Enanta Pharmaceuticals, Inc. ENTA
• Legend Biotech Corporation LEGN

Click here for accessing Benzinga's FDA Calendar

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 7)

• Acutus Medical, Inc. AFIB
• Adverum Biotechnologies, Inc. ADVM
• Akoya Biosciences, Inc. AKYA
• Amgen Inc. AMGN ( announced neurodegenerative disease drug collaboration with Nuemora)
• Angion Biomedica Corp. ANGN
• Applied DNA Sciences, Inc. APDN
• Applied Molecular Transport Inc. AMTI
• ARCA biopharma, Inc. ABIO
• Avenue Therapeutics, Inc. ATXI
• Aytu Biopharma, Inc. AYTU
• Aziyo Biologics, Inc. AZYO
• BiondVax Pharmaceuticals Ltd. BVXV
• BioSig Technologies, Inc. BSGM
• BioVie Inc. BIVI
• Black Diamond Therapeutics, Inc. BDTX
• Calliditas Therapeutics AB (publ) (NASDAQ: acquired full control of Genkyotex)
• Cellectis S.A. CLLS
• Chemomab Therapeutics Ltd. CMMB
• China SXT Pharmaceuticals, Inc. SXTC
• Clarus Therapeutics Holdings, Inc. CRXT
• Concert Pharmaceuticals, Inc. CNCE
• CureVac N.V. CVAC
• Cytosorbents Corporation (CTSO)
  XERS
• DICE Therapeutics, Inc. DICE
• Eiger BioPharmaceuticals, Inc. EIGR
• Esperion Therapeutics, Inc. ESPR
• First Wave BioPharma, Inc. FWBI
• Forma Therapeutics Holdings, Inc. FMTX (announced presentation of Phase 1 data for prostate cancer drug)
• Gain Therapeutics, Inc. GANX
• Galapagos NV GLPG
• Galecto, Inc. GLTO
• Graphite Bio, Inc. GRPH
• Harpoon Therapeutics, Inc. HARP
• Histogen Inc. HSTO
• HOOKIPA Pharma Inc. HOOK
• IMARA Inc. IMRA
• InMed Pharmaceuticals Inc. INM
• Inozyme Pharma, Inc. INZY
• Kala Pharmaceuticals, Inc. KALA
• Kaleido Biosciences, Inc. KLDO
• Kiromic BioPharma, Inc. (NASDAQ: KRBP
• Liminal BioSciences Inc. LMNL
• Lipocine Inc. LPCN
• Lixte Biotechnology Holdings, Inc. LIXT
• Longeveron Inc. LGVN
• Mesoblast Limited MESO
• Minerva Neurosciences, Inc. NERV
• Moleculin Biotech, Inc. MBRX
• MorphoSys AG MOR
• Nautilus Biotechnology, Inc. NAUT
• Neovasc Inc. NVCN
• NeuroBo Pharmaceuticals, Inc. NRBO
• NRx Pharmaceuticals, Inc. NRXP
• Nuwellis, Inc. NUWE
• Onconova Therapeutics, Inc. ONTX
• Oncorus, Inc. ONCR
• ORIC Pharmaceuticals, Inc. ORIC (presented initial clinical data from Phase 1b study of ORIC-101 in combination with enzalutamide, in metastatic prostate cancer patients)
• Oyster Point Pharma, Inc. OYST
• Orphazyme A/S ORPH
• Osmotica Pharmaceuticals plc OSMT (announced securing of $100 million in debt financing)
• Pasithea Therapeutics Corp. KTTA
• Petros Pharmaceuticals, Inc. PTPI
• Pluristem Therapeutics Inc. PSTI
• Plus Therapeutics, Inc. PSTV
• POINT Biopharma Global Inc. PNT
• Prelude Therapeutics Incorporated PRLD
• Pulmatrix, Inc. PULM
• Relay Therapeutics, Inc. RLAY
• Repare Therapeutics Inc. RPTX
• Repro Med Systems, Inc. KRMD
• Roivant Sciences Ltd. ROIV (listed Oct. 1 following a SPAC deal)
• Sangamo Therapeutics, Inc. SGMO
• Silverback Therapeutics, Inc. SBTX
• Solid Biosciences Inc. SLDB
• Spectrum Pharmaceuticals, Inc. SPPI
• Spruce Biosciences, Inc. SPRB
• Stoke Therapeutics, Inc. STOK
• Surrozen, Inc. SRZN
• Takeda Pharmaceutical Company Limited TAK
• TCR2 Therapeutics Inc. TCRR
• Teligent, Inc. TLGT
• Titan Pharmaceuticals, Inc. TTNP
• Turning Point Therapeutics, Inc. TPTX
• Unity Biotechnology, Inc. UBX
• Viveve Medical, Inc. VIVE
• XBiotech Inc. XBIT
• Xeris Pharmaceuticals, Inc.

Stocks In Focus

Quidel Pre-announces Strong Q3 Revenue Growth as COVID-19 Revenues Continue to Be Salubrious

Quidel Corporation QDEL said it expects total third-quarter revenues to be in the range of $505 million-$510 million, up 6-7% year-over-year. The company noted that it shipped over 45 million SARS tests, 135% higher than a year-ago. COVID-19 revenues are expected to be approximately $406 million, compared with $375.7 million in the year-ago period.

The stock was adding 6.45% to $145 in premarket trading.

Allogene CAR T Cell Therapy Trials Placed On Hold By FDA On Report Of Chromosomal Abnormality In a Patient

Allogene Therapeutics, Inc. ALLO said following a report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the ALPHA2 study, the U.S. Food and Drug Administration has placed a hold on its AlloCAR T clinical trials.
The company said it expects to provide additional updates in the coming weeks following consultation with the FDA. The FDA continues to actively review the end of Phase 1 materials submitted in anticipation for an ALLO-501A pivotal Phase 2 trial.

The stock was slumping 36.55% to $15.47 in premarket trading.

Codiak Sciences Says Sarepta Prematurely Cancels 2-Year License and Option Agreement For Use Of Exosomes In Non-viral Gene Delivery

Codiak BioSciences, Inc. CDAK said Sarepta Therapeutics, Inc. SRPT had notified it Oct. 1 that it was terminating early the two-year research license and option agreement, effective June 17, 2020, between the companies. The termination will be effective as of Dec. 3.

The agreement focused on the use of exosomes for non-viral delivery of AAV, gene-editing and RNA therapeutics to address five agreed targets associated with neuromuscular diseases.

As a result of the termination, each of the license and option granted to Sarepta shall terminate in its entirety, according to the terms of the agreement, and the company shall regain all rights previously granted to Sarepta.

Chemocentryx Announces FDA Nod For Drug to Treat Autoimmune Disease That Leads to Destruction of Small Blood Vessels

ChemoCentryx, Inc., CCXI announced FDA approval of Tavneos (avacopan), as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, in combination with standard therapy. ANCA-associated vasculitis is a systemic autoimmune disease in which over-activation of the complement system further activates neutrophils, leading to inflammation and eventual destruction of small blood vessels.

The stock was retreating 6.17% to $18.39 in premarket trading.

BeiGene's Brukinsa Gets Australian Regulatory Nod For Treating Slow-growing Lymphoma

BeiGene, Ltd. BGNE announced that Brukinsa has been approved in Australia for the treatment of adult patients with Waldenström's macroglobulinemia who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy.

Mirati, Sanofi Collaborate to Study Combo Therapy For Lung Cancer Patients With KRAS Mutation

Mirati Therapeutics, Inc. MRTX announced a non-exclusive clinical collaboration agreement with Sanofi SNY to evaluate the combination of adagrasib, its KRASG12C inhibitor, with Sanofi's investigational SHP2 inhibitor SAR442720, also known as RMC-4630.

The Phase 1/2 dose escalation and expansion study will evaluate the combination in patients with previously-treated non-small cell lung cancer and KRASG12C mutations.

Under the terms of the agreement, Sanofi will be responsible for sponsoring and operating the Phase 1/2 study, and jointly with Mirati, will oversee and share costs of the study.

Takeda's Cytomegalovirus Treatment Gets Unanimous Backing Of FDA Panel

Takeda announced FDA's Antimicrobial Drugs Advisory Committee voted unanimously to recommend use of maribavir for the treatment of refractory cytomegalovirus infection and disease with or without genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

The stock was up 1.25% to $14.55 in premarket trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

Nkarta Provides Updates On Its Early-stage NK Cell Therapy Candidates

In a clinical trial update, Nkarta, Inc. NKTX said it has commenced the clinical trial evaluating NKX019 in CD19+ advanced B cell malignancies. The company expects initial data from the study in 2022. Additionally, the company expects to release initial data from the Phase 1 study of NKX101 in acute myeloid leukemia and myelodysplastic syndrome in the first half of 2022.

Stealth Presents Positive Results From Animal Study of Its AML Candidate

At the 2021 Annual Northeast Amyotrophic Lateral Sclerosis meeting Stealth BioTherapeutics Corp MITO presented new promising data from a study evaluating the effects of SBT-272 in a murine model of amyotrophic lateral sclerosis.

Systemic administration of SBT-272 in rodents resulted in sustained SBT-272 levels across different regions of the brain and protected mitochondria against ischemic stress, confirming that the compound crosses the blood brain barrier and has mitoprotective effects, the company said.

In premarket trading, the stock was rising 2.16% to $1.42.

Intellia Falls On Insider Sales

Intellia Therapeutics, Inc. NTLA shares came under pressure after the company disclosed in a filing Crowley John, a director of the company, sold all 10,000 shares he acquired the exercising of options.

The stock was down 2.885 at $130.90 in premarket trading.

Humanigen's COVID-19 Treatment Candidate to Be Made Available In 16 European Countries Under A Managed Access Program

Humanigen, Inc. HGEN said it has entered into an arrangement with Clinigen Group, a global pharmaceutical services and products company, to implement a managed access program for lenzilumab, named LenzMAP.

LenzMAP, which is to be available in 16 European countries, will enable access to lenzilumab on a case-by-case basis for hospitalized patients with COVID-19 where the treating physician deems there to be no suitable alternatives and where regulations allow.

The stock was up 5.19% at $6.69 in premarket trading.

Offerings

Agile Therapeutics, Inc. AGRX announced that it intends to offer and sell shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering.

The stock was plunging 23% at 73.50 cents in premarket trading.

Cidara Therapeutics, Inc. CDTX announced that it has commenced concurrent but separate underwritten public offerings of its common stock and its Series X convertible preferred stock.

In premarket trading, the stock was receding 12.83% to $1.63.

On The Radar

Clinical Readouts/Presentations

Presentations at AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics

Mersana Therapeutics, Inc. MRSN presented new preclinical data for its antibody-drug conjugate XMT-2056, which targets a novel epitope of human epidermal growth factor receptor 2.

"New head-to-head preclinical data comparing XMT-2056 to TLR7/8-agonist ADC and systemically-administered STING agonist benchmarks further supports the potential advantages of XMT-2056 to offer greater efficacy and a wider therapeutic index," the company said.

eFFECTOR Therapeutics EFTR, in collaboration with investigators at Baylor College of Medicine, presented new positive data for zotatifin in animal models of triple-negative breast cancer.

eFFECTOR stock was rallying 28.48% to $14.75 in premarket trading.

Relay Therapeutics: initial results of RLY-4008 in patients with FGFR2-altered cholangiocarcinoma and multiple solid tumors (10:25 am)

Repare Therapeutics: Data from the Phase I TRESR trial of RP-3500 in patients with advanced solid tumors harboring synthetic lethal genomic alterations (3:15 pm)

The company clarified in a release late Thursday that there was an inadvertent early issuance of an abstract highlighting the upcoming oral presentation, which contained results taken from a very early cutoff date. The presentation due Friday will include both significantly more patient data as well as a later cut-off date and consequent longer follow up.

IPOs

IsoPlexis Corporation ISO priced its initial public offering of 8.333 million shares at $15 apiece compared to the estimated price range of $14-$16. The shares will begin trading on the Nasdaq under the ticker symbol "ISO."

The company's single cell proteomics platform has been adopted by the top global biopharmaceutical companies and comprehensive cancer centers in the U.S. to help develop more durable therapeutics, overcome therapeutic resistance, and predict patient responses for advanced immunotherapies, cell therapies, gene therapies, vaccines, and regenerative medicines.

Pyxis Oncology, Inc., PYXS, a portfolio company of venture capital fund Arix Bioscience plc, priced its IPO of 10.5 million shares of common stock at $16 per share for aggregate gross proceeds of $167.2 million. Pyxis' common stock is expected to begin trading on the Nasdaq under the ticker symbol "PYXS."