The Daily Biotech Pulse: NRx Stitches COVID-19 Drug Partnership, Protara Gets Nod For Starting Bladder Cancer Study, IGM Moves Beyond Oncology

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. 11)

• AstraZeneca Plc AZN (announced positive data for COVID-19 antibody treatment)
• Bicycle Therapeutics plc BCYC
• Enanta Pharmaceuticals, Inc. ENTA
• Itamar Medical Ltd. ITMR
• Legend Biotech Corporation LEGN
• Merus N.V. MRUS
• Zentalis Pharmaceuticals, Inc. ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 12)

• Absci Corporation ABSI
• Acutus Medical, Inc. AFIB
• Addex Therapeutics Ltd ADXN
• ADMA Biologics, Inc. ADMA
• Allogene Therapeutics, Inc. ALLO
• Ambrx Biopharma Inc. AMAM
• Amgen Inc. AMGN
• Applied Genetic Technologies Corporation AGTC
• Applied Molecular Transport Inc. AMTI
• Athenex, Inc. ATNX (provided positive update from Type A meeting with the Food and Drug Administration regarding approval of breast cancer drug)
• Axcella Health Inc. AXLA
• Aytu Biopharma, Inc. AYTU
• BiondVax Pharmaceuticals Ltd. BVXV
• BioSig Technologies, Inc. BSGM
• BioVie Inc. BIVI
• Cardiovascular Systems, Inc. CSII
• Centessa Pharmaceuticals Limited CNTA
• Century Therapeutics, Inc. IPSC
• Chemomab Therapeutics Ltd. CMMB
• DICE Therapeutics, Inc. DICE
• Diffusion Pharmaceuticals Inc. DFFN
• Eliem Therapeutics, Inc. ELYM
• Exscientia Holdings Limited EXAI (IPOed Oct. 1)
• Forma Therapeutics Holdings, Inc. FMTX
• Frequency Therapeutics, Inc. FREQ
• Gain Therapeutics, Inc. GANX
• GBS Inc. GBS
• Glaukos Corporation GKOS
• Guardion Health Sciences, Inc. GHSI
• Harpoon Therapeutics, Inc. HARP
• HOOKIPA Pharma Inc. HOOK
• IN8bio, Inc. INAB
• IsoPlexis Corporation ISO (IPOed Friday)
• Jasper Therapeutics, Inc. JSPR
• Kala Pharmaceuticals, Inc. KALA
• Kamada Ltd. KMDA
• Kiromic BioPharma, Inc. KRBP (announced strategic collaboration to advance its first allogeneic CAR-T clinical trial candidate, Alexis ISO-1)
• Kronos Bio, Inc. KRON
• Mustang Bio, Inc. MBIO
• Nautilus Biotechnology, Inc. NAUT
• NeuroBo Pharmaceuticals, Inc. NRBO
• NRx Pharmaceuticals, Inc. NRXP
• Omeros Corporation OMER
• OncoSec Medical Incorporated ONCS
• Orchard Therapeutics plc ORTX
• Pacira BioSciences, Inc. PCRX - announced deal to acquire Flexion Therapeutics, Inc. FLXN to expand non-opioid pain drug portfolio
• Petros Pharmaceuticals, Inc. PTPI
• Pharming Group N.V. PHAR
• Poseida Therapeutics, Inc. PSTX
• Prelude Therapeutics Incorporated PRLD
• Pulmatrix, Inc. PULM
• Pyxis Oncology, Inc. PYXS (IPOed Friday)
• Rain Therapeutics Inc. RAIN
• Recursion Pharmaceuticals, Inc. RXRX
• Repare Therapeutics Inc. RPTX
• Rhythm Pharmaceuticals, Inc. RYTM
• Sight Sciences, Inc. SGHT
• Silverback Therapeutics, Inc. SBTX
• T2 Biosystems, Inc. TTOO
• Talis Biomedical Corporation TLIS
• TFF Pharmaceuticals, Inc. TFFP
• Titan Pharmaceuticals, Inc. TTNP
• Xeris Pharmaceuticals, Inc. XERS

Stocks In Focus

Geron Announces Publication Of Positive Phase 2 Data For Imetelstat In Severe Myelofibrosis Patients

Geron Corporation GERN announced the publication in the Annals of Hematology of a paper entitled "Favorable Overall Survival with Imetelstat in Relapsed/Refractory Myelofibrosis Patients Compared with Real World Data," which details statistical analysis comparing data from the company's IMbark Phase 2 clinical trial to closely matched real world data.

For the imetelstat-treated patients, the median overall survival was approximately 30 months in comparison to approximately 12 months for best available treatment-treated patients from real world data, the company said.

"We are pleased with the publication of this important work as these analyses provide us further confidence in the use of OS as the primary endpoint for our ongoing confirmatory IMpactMF Phase 3 trial," said Aleksandra Rizo, Geron's chief medical officer.

The stock was advancing 7.46% at $1.44 in premarket trading.

IGM Sets Up Business Units Focusing On Infectious Diseases, Autoimmunity And Inflammation

IGM Biosciences, Inc. IGMS announced the formation of two business units, IGM Infectious Diseases and IGM Autoimmunity and Inflammation. These new business units will utilize and build upon IGM's platform technology to create and develop novel IgM and IgA antibodies to address infectious diseases, autoimmunity and inflammation.

Both business units will be headquartered in the greater Philadelphia area of Pennsylvania.

Mary Beth Harler, a former Bristol-Myers Squibb Company BMY executive, has been appointed as president of the IGM Autoimmunity and Inflammation business unit.

The company also announced the appointments of John Shiver and Tong-Ming Fu as chief strategy officer and chief scientific officer, respectively, of the IGM Infectious Diseases business unit.

NRx Confirms Manufacturing Partnership For COVID-19 Treatment Candidate

NRx said a revised investigational new drug module on the manufacturing of Zyesamo (aviptadil) was submitted to the FDA, with documentation that confirmed Nephron Pharmaceuticals is prepared to supply Zyesami on a commercial scale.

This module will now be used as part of the FDA's rolling review process supporting the new drug application for Zyesami.

NRx also said it has received notification that a European QP Auditor has completed an inspection at a separate manufacturing facility with no adverse findings. NRx awaits a QP Declaration that is required by the EU regulatory authorities for the release of Zyesami.

Zyesami is NRx's investigational product for patients with COVID-19 and it has been granted fast track designation by the FDA. It is undergoing Phase 3 trials.

NRx shares were moving up 9.14% to $7.40 in premarket trading.

Deciphera's Stomach Cancer Drug Approved In Switzerland

Deciphera Pharmaceuticals, Inc. DCPH announced that the Swiss Agency for Therapeutic Products has granted approval for Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib.

Related Link: The Week Ahead In Biotech (Oct. 10-16): Avadel FDA Decision, Conference Presentations And IPOs Take Center Stage

Protara's IND Application For TARA-002 In Bladder Cancer Cleared By FDA

Protara Therapeutics, Inc. TARA announced FDA's clearance for investigational NDA application for TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer.

Protara said it expects to initiate a Phase 1 clinical trial of TARA-002 in adults with high-grade NMIBC by the end of 2021.

In premarket trading, the stock was jumping 24.15% to $8.38.

Aerie Reports Positive Late-Stage Data For Ophthalmic Solution To Treat Interocular Pressure

Aerie Pharmaceuticals, Inc. AERI reported positive topline results for the the Phase 3 clinical trial in Japan evaluating netarsudil ophthalmic solution 0.02% versus ripasudil hydrochloride hydrate ophthalmic solution 0.4%.

The results showed that netarsudil 0.02% once daily was superior to ripasudil 0.4% twice daily in lowering intraocular pressure at week four, the primary endpoint for the study.

The stock was seen moving up 8.05% at $14.10 in premarket trading.

GSK's Consumer Unit Reportedly Attracts Interest From Private Equity Firms

As GlaxoSmithKline plc GSK plans to split up its business into consumer health care and new GSK, focused on pharma and vaccine, its consumer unit is attracting interest from private equity firms, according to Bloomberg.

Apart from private equity firms such as Blackstone, Carlyle Group and CVC Capital Partners, pharma and consumer goods companies may also be interested in bidding, the report said. The consumer unit could be valued at 40 billion pounds ($54.4 billion) or more in the eventuality of a sale, it added.

The stock was up 2.56% at $39.22 in premarket trading.

Lucira Health's COVID-19 Test Kit Approved In Singapore

Lucira Health, Inc. LHDX said it has received PSAR approval for its Lucira CHECK IT COVID-19 Test kit by Singapore's Health Sciences Authority. Lucira's test kit provides lab quality molecular results on the spot within 30 minutes.

Offerings

Relay Therapeutics, Inc. RLAY said it has commenced an underwritten public offering of $350 million of its common stock. All of the shares in the proposed offering are to be sold by Relay.

The stock was down 9.25% at $26.59 in premarket trading.

Bicycle announced that it has commenced an underwritten public offering of $125 million worth of its ADSs, each representing one ordinary share. All of the ADSs in the proposed offering will be sold by Bicycle.

In premarket trading, the stock was down 5.12% to $50.98.

Click here to access Benzinga's FDA Calendar.

On The Radar

Clinical Readouts

Inhibrx, Inc. INBX will host a live webcast presentation at 8:30 a.m. to provide interim results from a Phase 1 clinical trial evaluating the safety and pharmacokinetics of INBRX-101 in patients with alpha-1 antitrypsin deficiency.

CRISPR Therapeutics AG CRSP will host a virtual event at 4:30 p.m. to highlight clinical data from its ongoing Phase 1 study of CTX110 for the treatment of relapsed or refractory B-cell malignancies.

American Society of Retina Specialists Annual Meeting Presentations

Aerie Pharma: Topline results from the AR-1105 (dexamethasone intravitreal implant) Phase 2 clinical trial in patients with macular edema due to retinal vein occlusion (11:22 a.m.)

Outlook Therapeutics, Inc. OTLK: data from supplemental safety study for ONS-5010 / Lytenava, an investigational ophthalmic formulation of bevacizumab for use in retinal indications (12:08 a.m. to 12:14 a.m.)

Earnings

Enzo Biochem, Inc. ENZ (Tuesday, Oct. 12, before the market open)

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