The Daily Biotech Pulse: Lilly, Regeneron Ink COVID-19 Drug Deal With US, Regulatory Setback For Calliditas, Theravance To Cut 75% Jobs, 4 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 Sept. 14)

  • Alcon Inc. ALC
  • aTyr Pharma, Inc. LIFE (reacted to positive analyst action following a positive clinical readout announced Monday)
  • Aurinia Pharmaceuticals Inc. AUPH
  • BELLUS Health Inc. BLU
  • Itamar Medical Ltd. ITMR
  • IVERIC bio, Inc. ISEE
  • Kezar Life Sciences, Inc. KZR
  • PPD, Inc. PPD
  • Syneos Health, Inc. SYNH
  • Zentalis Pharmaceuticals, Inc. ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 14)

  • ACADIA Pharmaceuticals Inc. ACAD
  • Acutus Medical, Inc. AFIB
  • Avanos Medical, Inc. AVNS
  • Aditxt, Inc. ADTX
  • ADMA Biologics, Inc. ADMA
  • Alzamend Neuro, Inc. ALZN
  • Aytu Biopharma, Inc. AYTU
  • AzurRx BioPharma, Inc. AZRX (reacted to CEO James Sapirstein's comments on First Wave Biopharma acquisition)
  • Concert Pharmaceuticals, Inc. CNCE
  • CorMedix Inc. CRMD
  • CVRx, Inc. CVRX
  • Eiger BioPharmaceuticals, Inc. EIGR
  • Esperion Therapeutics, Inc. ESPR
  • Forte Biosciences, Inc. FBRX
  • Gain Therapeutics, Inc. GANX
  • Gamida Cell Ltd. GMDA
  • Indaptus Therapeutics, Inc. INDP
  • InMed Pharmaceuticals Inc. INM
  • Inozyme Pharma, Inc. INZY
  • Molecular Templates, Inc. MTEM
  • MorphoSys AG MOR
  • NeuroPace, Inc. NPCE
  • Oyster Point Pharma, Inc. OYST
  • Pharming Group N.V. PHAR
  • RedHill Biopharma Ltd. RDHL (announced Phase 2/3 study evaluating opaganib in hospitalized patients with severe COVID-19 pneumonia did not meet its primary endpoint)
  • Seres Therapeutics, Inc. MCRB
  • Spruce Biosciences, Inc. SPRB
  • TherapeuticsMD, Inc. TXMD
  • TransCode Therapeutics, Inc. RNAZ
  • TScan Therapeutics, Inc. TCRX
  • Unity Biotechnology, Inc. UBX
  • Zynex, Inc. ZYXI

Click here for accessing Benzinga's FDA Calendar

Stocks In Focus

Calliditas Says FDA Extends Review Period For Autoimmune Renal Disease Drug by 3 Months

Calliditas Therapeutics AB CALT said the Food and Drug Administration has extended the PDUFA goal date for its new drug application, seeking accelerated approval for Nefecon as treatment option for autoimmune renal disease, primary IgA nephropathy, to Dec. 15.

In its review of the NDA, the FDA has requested further analyses of the NeflgArd trial data which it provided to the FDA. The agency has classified these analyses as a major amendment to the NDA, necessitating the review period extension.

The stock was slipping 7.56% to $22.33 in premarket trading.

ObsEva Submits Regulatory Application For Approval of Linzagolix In Uterine Fibroids

ObsEva SA OBSV announced it has submitted an NDA to the FDA for linzagolix for the treatment of uterine fibroids. Linzagolix, the company said, is an oral GnRH receptor antagonist with potential best-in-class efficacy, favorable tolerability profile, and unique and flexible dosing options. If approved, linzagolix will be the only GnRH antagonist in uterine fibroids with a low dose non-add-back therapy option.

The stock was up 5.32% to $3.17 in premarket trading.

Regeneron, Lilly Ink Deal to Supply Additional Doses of Antibody COVID-19 Treatments to U.S. Government

Regeneron Pharmaceuticals, Inc. REGN said the U.S. Department of Health and Human Services and the Department of Defense will purchase 1.4 million additional doses of REGEN-COV.

New agreement for 1.4 million doses of REGEN-COV, brings total purchased by the U.S. government to nearly 3 million doses.

Eli Lilly and Company LLY announced an additional purchase by the U.S. government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. As part of the agreement, Lilly will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the U.S. government, with approximately 200,000 doses expected to ship the third quarter and the remaining to be shipped in the fourth quarter.

This transaction is expected to generate approximately $330 million in revenue for Lilly in the second half of 2021.

Regeneron shares were advancing 1.92% to $657.56 in premarket trading, while Lilly was adding 0.21% to $233.59.

Sage's SAGE-718 Gets Fast Track Designation In Huntington's Disease

Sage Therapeutics, Inc. SAGE announced that the FDA has granted Fast Track Designation to SAGE-718 for development as a potential treatment for Huntington's disease.

In premarket trading, the stock was gaining 6.83% to $46.58.

Related Link: The Week Ahead In Biotech: Calliditas FDA Decision, Adcom Review For Pfizer/BioNTech COVID-19 Vaccine, Oncology Conference And IPOs

GenSight Says DSMB Found No Safety Issues With GS030-Gene Therapy Combo Phase 1/2 Study In Retinitis Pigmentosa

GenSight Biologics S.A. GSGTF announced that the independent Data Safety Monitoring Board completed its third safety review of the ongoing PIONEER Phase 1/2 clinical trial of GS030 combining AAV2-based gene therapy with optogenetics for the treatment of Retinitis Pigmentosa.

The DSMB found no safety issue in the third cohort of patients, who received an intravitreal injection with the highest dose among the three cohorts studied to date, followed by the use of a wearable optronic visual stimulation device.

Based on GS030's safety profile, the DSMB recommended selecting this dose for the extension cohort and using the protocol without any modification, the company said.

Hookipa To Collaborate With Merck In Head and Neck Cancer Study

HOOKIPA Pharma Inc. HOOK announced it has entered into a clinical collaboration and supply agreement with Merck & Co., Inc. MRK to evaluate the combination of HB-200, a arenaviral immunotherapeutic, and Merck's Keytruda as first-line treatment for patients with advanced head and neck squamous cell carcinoma.

Hookipa shares were adding 5.47% to $ 6.56 in premarket trading.

BeiGene's Brukinsa Approved For Blood Cancer In U.S.

BeiGene, Ltd. BGNE announced that Brukinsa has received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen.

The stock was up 3.28% to $381 in premarket trading.

Thervance to Reduce Headcount By 75% Amid Narrowed Focus On Respiratory Therapeutics

Theravance Biopharma, Inc. TBPH announced strategic actions to focus on leveraging its expertise in developing and commercializing respiratory therapeutics in order to maximize shareholder value.

The action included a reduction in headcount by 75%, or an estimated 270 positions. The company expects annualized operating cost savings of about $165 million in 2022.

By implementing these strategic actions, Theravance Biopharma expects to become sustainably cash flow positive beginning in the second half of 2022.

The stock was plunging 28.61% to $5.74 in premarket trading.

Cantex Liquidates Equity Interest In Chimerix

Cantex Pharma announced that it has sold 6.5 million shares of Chimerix, Inc. CMRX in brokerage transactions at a price of $5.75 per share, less brokerage commissions and fees.

In premarket trading, Chimerix stock was down 4.04% at $6.17.

Veracyte's Genomic Classifier For Detecting Prostate Cancer Included In NCCN Guidelines

Veracyte, Inc. VCYT announced that its Decipher Prostate RP genomic classifier is uniquely recommended in the 2022 National Comprehensive Cancer Network Clinical Practice Guidelines for Oncology to guide treatment decisions for men with prostate cancer.

"The NCCN's designation is unique to Decipher Prostate RP and underscores the extensive clinical validation and clinical utility data behind the test. We believe this recommendation will ultimately enable more men to receive the treatment they need, while reducing unnecessary therapy," the company said.

Xeris Shareholders Approve Its Proposed Acquisition of Strongbridge

Xeris Pharmaceuticals, Inc. XERS announced that its stockholders have voted to approve the previously announced proposed acquisition of Strongbridge Biopharma plc SBBP by Xeris.

The acquisition was previously approved by Strongbridge shareholders. Upon close of the acquisition, the business of Xeris and Strongbridge will be combined under an entity called Xeris Biopharma Holdings, Inc.

The acquisition is expected to close early in the fourth quarter of 2021, subject to customary closing conditions.

Athenex Gains On Insider Buying

Athenex, Inc. ATNX disclosed in a filing with the SEC that Jinn Wu, a director of the company's board, bought 50,000 shares in the company at a price of $3.22 per share.

The stock was adding 8.18% to $3.44 in premarket trading.

Offerings

Avalo Therapeutics, Inc. AVTX announced that it intends to offer for sale, shares of its common stock in an underwritten public offering. All of the shares of common stock will be offered by Avalo.

The stock was plunging 14.06% to $2.2 in premarket trading.

On The Radar

Clinical Readouts/Presentations

BioXcel Therapeutics, Inc. BTAI is scheduled to present updates from its Phase 1b/2 trial of BXCL701 in aggressive forms of prostate cancer in a poster session at the 2021 European Society for Medical Oncology Congress. The poster will be available starting, Wednesday at 6:05 pm.

IPOs

Procept Biorobotics Corporation PRCT priced its upsized initial public offering of 6.556 million shares at $25, above the estimated price range of $22-$24. Procept Biorobotics, a commercial-stage surgical robotics company, expects to list its shares on the Nasdaq under the ticker symbol "PRCT."

Tyra Biosciences Inc. TYRA, a Carlsbad, California-based precision-oncology company, priced its upsized IPO of 10.8 million share at $16, at the upper bound of the estimated price range of $14-$16. The shares will begin trading on the Nasdaq under the ticker symbol "TYRA."

Dice Therapeutics, Inc. DICE priced its upsized IPO of 12 million shares at $17 apiece compared to the estimated price range of $15-$17. The South San Francisco, California-based company is a biopharma, leveraging its proprietary technology platform to build a pipeline of novel oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas. The shares are expected to begin trading on the Nasdaq under the ticker symbol "DICE."

Pasithea Therapeutics Corp. KTTA, a biotech focusing on psychiatric and neurological disorders, priced its upsized IPO of 4.8 million units, with each unit consisting of one share of common stock and one warrant to purchase one share of common stock at a public offering price of $5 per Unit, for aggregate gross proceeds of approximately $24 million.

The company said it has received approval to list its common stock and warrants on the Nasdaq, with its common stock trading under the symbol "KTTA" and the warrants trading under the symbol "KTTAW."

Posted In: BiotechNewsPenny StocksOfferingsSmall CapFDAIPOsGeneral

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