The Daily Biotech Pulse: Ardelyx Sinks On Regulatory Setback, AnPac Issues Positive Preannouncement, European Nod For Myovant, HCW Biologics Debuts On Wall Street

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 July 19)

Cytokinetics, Incorporated CYTK (announced topline results from Cohorts 1 and 2 of the Phase 2 study of CK-274 in obstructive outflow disease in hypertrophic cardiomyopathy)
Forward Pharma A/S FWP
ResMed Inc. NRMD
Legend Biotech Corporation LEGN
Moderna, Inc. MRNA (extended gains on recent momentum)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 19)

4D pharma plc LBPS
Adaptimmune Therapeutics plc ADAP
Adverum Biotechnologies, Inc. ADVM
Aerovate Therapeutics, Inc. AVTE (IPOed June 30)
Agile Therapeutics, Inc. AGRX
Allena Pharmaceuticals, Inc. ALNA
Alzamend Neuro, Inc. ALZN
Aptose Biosciences Inc. APTO
ARCA biopharma, Inc. ABIO
Ascendis Pharma A/S ASND
Assembly Biosciences, Inc. ASMB
Assertio Holdings, Inc. ASRT
Athersys, Inc. ATHX
Athira Pharma, Inc. ATHA
Atreca, Inc. BCEL
Avenue Therapeutics, Inc. ATXI
Aytu Biopharma, Inc. AYTU
AzurRx BioPharma, Inc. AZRX
Baudax Bio, Inc. BXRX
Biomea Fusion, Inc. BMEA
Biophytis SA BPTS
Centessa Pharmaceuticals Limited CNTA
Cogent Biosciences, Inc. COGT
Coherus BioSciences, Inc. CHRS
Concert Pharmaceuticals, Inc. CNCE
CytomX Therapeutics, Inc. CTMX
Design Therapeutics, Inc. DSGN
DURECT Corporation DRRX
Edgewise Therapeutics, Inc. EWTX
Eloxx Pharmaceuticals, Inc. ELOX
Enveric Biosciences, Inc. ENVB
Esperion Therapeutics, Inc. ESPR
Eton Pharmaceuticals, Inc. ETON
Exelixis, Inc. EXEL
Flexion Therapeutics, Inc. FLXN
Galecto, Inc. GLTO
Genfit SA GNFT
Global Blood Therapeutics, Inc. GBT
GlycoMimetics, Inc. GLYC
Gossamer Bio, Inc. GOSS
Heron Therapeutics, Inc. HRTX
HOOKIPA Pharma Inc. HOOK
IMV Inc. IMV (reacted to a proposed common stock offering)
InflaRx N.V. IFRX
Inhibikase Therapeutics, Inc. IKT
InMed Pharmaceuticals Inc. INM
Innate Pharma S.A. IPHA
iRhythm Technologies, Inc. IRTC
Kala Pharmaceuticals, Inc. KALA
Kamada Ltd. KMDA
Kiromic BioPharma, Inc. KRBP
Lava Therapeutics B.V. LVTX
Leap Therapeutics, Inc. LPTX
Liminal BioSciences Inc. LMNL
Madrigal Pharmaceuticals, Inc. MDGL
Medicenna Therapeutics Corp. MDNA
Mersana Therapeutics, Inc. MRSN
Metacrine, Inc. MTCR
Minerva Neurosciences, Inc. NERV
Molecular Templates, Inc. MTEM
MorphoSys AG MOR
Nabriva Therapeutics plc NBRV
Neoleukin Therapeutics, Inc. NLTX
NexImmune, Inc. NEXI
NextCure, Inc. NXTC
NuCana plc NCNA
Nuvation Bio Inc. NUVB
OncoSec Medical Incorporated ONCS
Orchard Therapeutics plc ORTX
Otonomy, Inc. OTIC
Pharming Group N.V. PHAR
Pharvaris N.V. PHVS
Phio Pharmaceuticals Corp. PHIO
Pluristem Therapeutics Inc. PSTI
PolyPid Ltd. PYPD
Protara Therapeutics, Inc. TARA
Regencell Bioscience Holdings Limited RGC
Reviva Pharmaceuticals Holdings, Inc. RVPH
Rockwell Medical, Inc. RMTI
Sarepta Therapeutics, Inc. SRPT
Sera Prognostics, Inc. SERA (IPOed Thursday)
Sigilon Therapeutics, Inc. SGTX
Soleno Therapeutics, Inc. SLNO
Sonnet BioTherapeutics Holdings, Inc. SONN
Sonoma Pharmaceuticals, Inc. SNOA
T2 Biosystems, Inc. TTOO
Teligent, Inc. TLGT
TherapeuticsMD, Inc. TXMD
Theravance Biopharma, Inc. TBPH
TransCode Therapeutics, Inc. RNAZ (IPOed July 9)
Travere Therapeutics, Inc. TVTX
TScan Therapeutics, Inc. TCRX (IPOed Friday)
Unicycive Therapeutics, Inc. UNCY (IPOed July 13)
Universe Pharmaceuticals INC UPC
uniQure N.V. QURE
VectivBio Holding AG VECT
Vivos Therapeutics, Inc. VVOS
Vor Biopharma Inc. VOR
Voyager Therapeutics, Inc. VYGR
VYNE Therapeutics Inc. VYNE
Yumanity Therapeutics, Inc. YMTX
ZIVO Bioscience, Inc. ZIVO
Zogenix, Inc. ZGNX

Stocks In Focus

FDA Identifies Deficiencies In Ardelyx's NDA For Drug To Treat Elevated Blood Phosphorous Levels

Ardelyx, Inc. ARDX said it received a July 13 letter from the Food and Drug Administration stating that, as part of its ongoing review of the company's new drug application for Tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.

The notification does not reflect a final decision on the information under review. The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA Monday that the request for a meeting was denied.

"While the FDA has not provided specific details regarding the deficiencies, the FDA noted that a key issue is the size of the treatment effect and its clinical relevance," Ardelyx said.

Tenapanor's PDUFA goal date was fixed for July 29.

The stock was plunging 73.25% to $2.06 premarket Tuesday.

Myovant Receives European Commission Approval For Uterine Fibroid Treatment

Myovant Sciences MYOV announced the European Commission has approved the marketing authorization application for Ryeqo for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use.

The EC decision is valid in all 27 member states of the European Union, as well as Iceland, Norway and Liechtenstein.

Immunome Says COVID-19 Antibody Cocktail Effective Against Delta Variant In Animal Study

Immunome, Inc. IMNM announced that its three-antibody cocktail, IMM-BCP-01, has demonstrated potent neutralizing activity against the SARS-CoV-2 Delta variant in pre-clinical pseudovirus testing.
Furthermore, IMM-BCP-01 showed in-vitro activity via non-neutralizing mechanisms, such as complement fixation, which Immunome expects will enable viral clearance.

The stock was jumping 25% to $20.80 in premarket trading.

PLx Pharm's Liquid-Filled Aspirin Capsule To Land On Walgreens Shelves In August

Three stock-keeping units of Vazalore, PLx Pharma Inc.'s PLXP first and only FDA-approved liquid-filled aspirin capsules, will be available in over 8,000 Walgreens Boots Alliance, Inc. WBA stores nationwide later in August.

In premarket trading, the stock was adding 9.36% to $18.57.

Merck Announces Positive Phase 2a Data For Islatravir As Pre-Exposure HIV Prophylaxis

Merck & Co, Inc. MRK announced results from a Phase 2a clinical trial evaluating the safety, tolerability and pharmacokinetics of six monthly oral doses over 24 weeks of islatravir, its investigational nucleoside reverse transcriptase translocation inhibitor versus placebo for pre-exposure prophylaxis of HIV-1 infection in adults at low-risk of contracting HIV-1.

After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo. The levels of islatravir in peripheral blood mononuclear cells (PBMCs) also remained above the pre-specified efficacy PK threshold for PrEP at both doses studied, eight weeks after the last study dose.

The stock was up 0.16% at $77.17 in premarket trading.

Amneal Lands FDA Approval For Generic Version of Eye Inflammation Treatment

Amneal Pharmaceuticals, Inc. AMRX announced that it has received abbreviated NDA approval from the FDA for the generic version of TobraDex, which adds another complex ophthalmic product to the generics portfolio.

Dexamethasone and Tobramycin Ophthalmic Suspension 0.3%/0.1% is the generic version of TobraDex, which is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

The stock was seen moving up 4.4% to $4.51 in premarket trading.

Lantern Announces Positive Preclinical Data For Pancreatic Cancer Drug

Lantern Pharma LTRN announced positive new data from its ongoing pancreatic cancer collaboration with the Pancreatic Cancer Institute at Fox Chase Cancer Center.

Preclinical data demonstrated that the drug candidate, LP-184, demonstrated significant and rapid pancreatic tumor shrinkage, by over 90%, in in-vivo mouse models in eight weeks, the company said. In comparison, the tumors in the untreated mice grew by over eleven-fold in volume during the same eight-week period, it added.

The stock was rallying 20.08% to $15.30 in premarket trading.

Integra LifeSciences Announces Positive Data For Diabetic Foot Ulcer Treatment

Integra LifeSciences Corporation IART announced positive clinical outcomes for PriMatrix Dermal Repair Scaffold for the management of hard to heal diabetic foot ulcers. The study demonstrated that in most cases, one application of PriMatrix plus standard of care healed 60% of DFUs in 12 weeks versus 35% of DFUs that healed in 12 weeks with SOC for the per protocol analysis.

AnPac Bio-Medical Preannounces Strong Testing Volume Growth For Q2

AnPac Bio-Medical Science ANPC pre-announced Tuesday that it has experienced strong growth in test volume in the first half year of 2021, with total number of paid customers and testing volume increasing almost 110% compared with the same period in 2020.

In addition, in the second quarter, the total paid tests and paid cancer tests increased approximately 280% and approximately 270%, respectively, quarter-over-quarter. Other tests including new test products launched in 2020 have also grown, the company said.

In premarket trading, the stock was up 9.23% at $4.38.

Offerings

Brickell Biotech, Inc. BBI said it has entered into an underwriting agreement with H.C. Wainwright & Co. under which the underwriter has agreed to purchase on a firm commitment basis 8.065 million shares of common stock of the company at a price to the public of 62 cents per share, less underwriting discounts and commissions.

The closing of the public offering is expected to occur on or about July 22.

The stock was down 2,085% at 58.31 cents in premarket trading.

CytoKinetics said, subject to market and other conditions, it plans to offer $200 million in shares of its common stock in an underwritten public offering. All of the shares of common stock in the offering will be sold by Cytokinetics.

In premarket trading, the stock was up 2.33% at $27.63.

On The Radar

PDUFA Dates

The FDA is expected to rule on Albireo Pharma, Inc.'s ALBO new drug application for odevixibat for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis, a rare inherited progressive liver disease.
Bylvay has been approved as the brand name for odevixibat.

Earnings

Intuitive Surgical, Inc. ISRG (after the close)

IPOs

HCW Biologics Inc., a preclinical stage biopharma focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, priced its initial public offering of 7 million shares at $8 per share. for gross proceeds of approximately $56 million. All of the shares of common stock are being offered by the company. The shares are expected to begin trading on the Nasdaq under the ticker symbol "HCWB."

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