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The Daily Biotech Pulse: Chiasma, Heron Await FDA Decisions, DBV Restructures, 3 Biopharmas Make Wall Street Debuts

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 June 25)

Benzinga · -

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 June 25)

  • Brainstorm Cell Therapeutics Inc (NASDAQ:BCLI)
  • Cardiff Oncology Inc (NASDAQ:CRDF)
  • Cerus Corporation (NASDAQ:CERS)
  • Dynavax Technologies Corporation (NASDAQ:DVAX)
  • ESSA Pharma Inc (NASDAQ:EPIX)
  • Fennec Pharmaceuticals Inc (NASDAQ:FENC)
  • Forma Therapeutics Holdings Inc (NASDAQ:FMTX)
  • Horizon Therapeutics PLC (NASDAQ:HZNP)
  • IGM Biosciences Inc (NASDAQ:IGMS)
  • Immunovant Inc (NASDAQ:IMVT)
  • Inovio Pharmaceuticals Inc (NASDAQ:INO)
  • Keros Therapeutics Inc (NASDAQ:KROS)
  • KITOV PHARMA LT/S ADR (NASDAQ:KTOV)
  • Liquidia Technologies Inc (NASDAQ:LQDA)
  • Meridian Bioscience, Inc. (NASDAQ:VIVO)
  • Novavax, Inc. (NASDAQ:NVAX)
  • Ocular Therapeutix Inc (NASDAQ:OCUL)
  • ORIC Pharmaceuticals Inc (NASDAQ:ORIC)
  • Pliant Therapeutics Inc (NASDAQ:PLRX)
  • Protagonist Therapeutics Inc (NASDAQ:PTGX)
  • Relmada Therapeutics Inc (NASDAQ:RLMD)
  • Replimune Group Inc (NASDAQ:REPL)
  • ResMed Inc. (NYSE:RMD)
  • Rhythm Pharmaceuticals Inc (NASDAQ:RYTM)
  • United Therapeutics Corporation (NASDAQ:UTHR) (Wedbush maintained a Buy rating on the shares)
  • Vaxart Inc (NASDAQ:VXRT) (announced a manufacturing partnership with Attwill Medical Solutions for its COVID-19 vaccine)
  • West Pharmaceutical Services Inc. (NYSE:WST)
  • Y-mAbs Therapeutics, Inc (NASDAQ:YMAB)
  • Zentalis Pharmaceuticals Inc (NASDAQ:ZNTL)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 25)

  • Vaccinex Inc (NASDAQ:VCNX)

Stocks In Focus

Zogenix Seizure Drug Approved With REMS Restriction

Zogenix, Inc. (NASDAQ:ZGNX) said the FDA has approved its Fintepla oral solution, CIV, for the treatment of seizures associated with Dravet syndrome in patients 2 and older. The company said the drug will be launched through a restricted distribution program, the FINTEPLA Risk Evaluation and Mitigation Strategy Program, and is expected to be available through its specialty pharmacy partner by the end of July.

The stock was rallying by 16.54% to $32.77 premarket Friday. 

MediciNova Announces Publication Of Positive Preclinical Data For MN-166 In Glioblastoma

MediciNova, Inc. (NASDAQ:MNOV), which recently announced a European intent to grant patent, announced positive preclinical findings published in Frontiers in Immunology regarding the prospect of MN-166 as an adjunct treatment for glioblastoma.

In premarket trading, the stock was higher by 13.07% at $6.40. 

Altimmune Shares Gain On Fund Buying

Altimmune Inc (NASDAQ:ALT) shares rose after Venrock Healthcare Partners II disclosed in a SEC filing a 20.8% stake in Altimmune as of June 15.

The stock was up 24.05% at $11.40 premarket. 

See also: The Week Ahead In Biotech: Karyopharm, Zogenix, Heron, Chiasma On The Radar Ahead Of FDA Decisions

AbbVie's Allergan Unit Gets Complete Response Letter For Eye Disorder Drug

AbbVie Inc's (NYSE:ABBV) Allergan unit and and Molecular Partners said the FDA has issued a Complete Response Letter to the BLA for Abicipar pegol, an investigational DARPin therapy for patients with neovascular age-related macular degeneration.

The FDA said the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk, prompting the CRL. AbbVie said it plans to meet with the FDA to discuss its comments and determine next steps.

In premarket trading Friday, AbbVie shares were adding 0.52% to $97.49. 

DBV Announces Cost Cuts, Including Workforce Reduction

The FDA has yet to decide on the BLA from DBV TECHNOLOGIE/S ADR (NASDAQ:DBVT) for its  peanut allergy skin patch. The company said it is initiating a global and comprehensive restructuring plan that includes a significant reduction in workforce.

The company said it is contemplating cost reduction measures across the organization while preserving core activities and competencies.

DBV said it now expects its balance of cash and cash equivalents of 262.4 million euros ($294.2 million) at the end of the first quarter of 2020 will be sufficient to fund operations significantly beyond the prior guidance of the first quarter of 2021.

The stock was sliding 15% to $4.59 in premarket trading Friday.

Keros To Join Russell 2000 Index

Keros said it is set to join the Russell 2000 Index effective after the close of the U.S. markets June 26.

Axsome Gets Breakthrough Therapy Designation For AXS-05

Axsome Therapeutics Inc (NASDAQ:AXSM) said the FDA has granted Breakthrough Therapy designation for AXS-05 for the treatment of Alzheimer's disease agitation.

In premarket trading Friday, the stock was adding 9.61% to $83.97.

Offerings

Milestone Scientific Inc. (NYSE:MLSS) priced its underwritten offering of 6.52 million shares of its common stock and warrants to purchase up to an aggregate of 3.26 million shares of its common stock.

Each share of common stock is being sold together with a warrant to purchase 0.5 of a share at a combined price of $2.15. The company expects to raise gross proceeds of $14 million from the offering. The offering is expected to close on or about June 30.

The stock was down 18.37% to $2 premarket Friday.

Medical device maker Soliton Inc. (NASDAQ:SOLY) announced that it intends to offer shares of its common stock in an underwritten public offering.

In premarket trading Friday, the stock was plunging 16.03% to $9.95. 

On The Radar

PDUFA Dates

The FDA is also expected to rule on Chiasma Inc's (NASDAQ:CHMA) NDA for Mycapssa, which is being evaluated as a maintenance therapy for acromegaly.

Heron Therapeutics Inc (NASDAQ:HRTX) is awaiting an FDA nod for its HTX-011 as a treatment option for post-operative pain.

Intercept Pharmaceuticals Inc (NASDAQ:ICPT) has a PDUFA date of June 26 for the NDA for its NASH drug candidate obeticholic acid. With an Adcom meeting originally scheduled for June 9 having been postponed, it is less likely that an approval will come through.

IPOs

Fusion Pharmaceuticals. a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, priced its initial public offering of 12.5 million shares at $17 per share, above the estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol "FUSN."

Akouos, Inc., which is developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for people who live with disabling hearing loss, priced its IPO of 12.5 million shares at $17 per share. The shares will be listed on the Nasdaq under the ticker symbol "AKUS."

PolyPid Ltd, a Phase 3 clinical-stage pharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, priced its IPO of 3.75 million shares at $16 per share compared to the estimated price range of $15-$17. The shares will begin trading on the Nasdaq under the ticker symbol "PYPD."

Related Link: Evoke Gets FDA Nod For Gimoti, A Nasally-Administered Gastroparesis Drug