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

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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 (NASDAQ: 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 (NASDAQ: FWP)
  • ResMed Inc. (NYSE: NRMD)
  • Legend Biotech Corporation (NASDAQ: LEGN)
  • Moderna, Inc. (NASDAQ: MRNA) (extended gains on recent momentum)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 19)

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

Stocks In Focus

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

Ardelyx, Inc. (NASDAQ: 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 (NYSE: 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. (NASDAQ: 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 (NASDAQ: PLXP) first and only FDA-approved liquid-filled aspirin capsules, will be available in over 8,000 Walgreens Boots Alliance, Inc. (NYSE: 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. (NYSE: 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.

Related Link: The Week Ahead In Biotech: Earnings Kickstart With J&J And Biogen, Albireo Awaits FDA Decisions, More IPOs

Amneal Lands FDA Approval For Generic Version of Eye Inflammation Treatment

Amneal Pharmaceuticals, Inc. (NYSE: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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. (NASDAQ: 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 (NASDAQ: 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. (NASDAQ: 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."

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

 

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