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)

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

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 25)

Vaccinex Inc VCNX

Stocks In Focus

Zogenix Seizure Drug Approved With REMS Restriction

Zogenix, Inc. 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. 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 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.

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

AbbVie Inc's 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 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 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. 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. 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 CHMA NDA for Mycapssa, which is being evaluated as a maintenance therapy for acromegaly.

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

Intercept Pharmaceuticals Inc 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."

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