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The Daily Biotech Pulse: FDA Nod For Aquestive, Tetraphase M&A Plot Thickens, Amarin's Vascepa In COVID Fray

Shanthi Rexaline

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 May 21)

  • ADC Therapeutics SA (NYSE: ADCT) (IPOed May 15)
  • Allogene Therapeutics Inc (NASDAQ: ALLO)
  • AstraZeneca plc (NYSE: AZN) ( announced $1 billion BARDA funding for coronavirus vaccine program)
  • Biondvax Pharmaceuticals Ltd – ADR (NASDAQ: BVXV)
  • Cellectis SA (NASDAQ: CLLS)
  • ChemoCentryx Inc (NASDAQ: CCXI)
  • Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP)
  • Cue Biopharma Inc (NASDAQ: CUE)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • Harpoon Therapeutics Inc (NASDAQ: HARP)
  • Horizon Therapeutics PLC (NASDAQ: HZNP)
  • Intellia Therapeutics Inc (NASDAQ: NTLA)
  • Kamada Ltd. (NASDAQ: KMDA)
  • Minerva Neurosciences Inc (NASDAQ: NERV)
  • Ovid Therapeutics Inc (NASDAQ: OVID)
  • Passage Bio Inc (NASDAQ: PASG)(FDA granted Rare Pediatric Disease designation to its gene therapy PBGM01 broadly for the treatment of GM1 gangliosidosis)
  • Soleno Therapeutics Inc (NASDAQ: SLNO)
  • Surface Oncology Inc (NASDAQ: SURF)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 21)

  • Akorn, Inc. (NASDAQ: AKRX) (filed for Chapter 11 bankruptcy)
  • Digirad Corporation (NASDAQ: DRAD)
  • Genfit SA (NASDAQ: GNFT)

Related Link: These 6 Coronavirus Vaccine Candidates Are The Likeliest To Succeed, Says Morgan Stanley

Stocks In Focus Aquestive's Partnered Parkinson's Drug Gets FDA Nod

Aquestive Therapeutics Inc's (NASDAQ: AQST) development partner Sunovion announced FDA approval for Kynmobi sublingual film - APL-130277 - for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease. The drug is expected to be available in the U.S. pharmacies in September.

Following the approval, Aquestive said it plans to monetize its PharmFilm based therapies.

"We continue to expect that we will receive between $50 to $100 million of non-dilutive capital from the monetization, in one or a series of transactions," the company said.

The stock rose 5.2% to $6.47 in after-hours trading.

Syndax's Lead Breast Cancer Drug Flunks Late-stage Study

Syndax Pharmaceuticals Inc (NASDAQ: SNDX) said a late-stage study that evaluated its investigational compound entinostat along with exemestane in patients with HR+, HER2- breast cancer who have progressed on a non-steroidal aromatase inhibitor did not achieve the primary endpoint of demonstrating a statistically significant overall survival benefit over hormone therapy alone.

The study was conducted by ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute.

The stock slumped 19.41% to $16.52 in after-hours trading.

Tiziana To Spin-off Its Personalized Medicines Businesses

TIZIANA LF SCIE/S ADR (NASDAQ: TLSA) said it intends to demerge its StemPrintER and SPARE genomics-based personalized medicine businesses into a separate company and effect a capital reduction to facilitate the spin-out and listing of StemPrintER as an independent entity.

Amarin To Support Pilot Study Of Vascepa In Treating COVID-19

Amarin Corporation plc (NASDAQ: AMRN) said it supports a clinical trial to investigate the effects of its Vascepa on inflammatory biomarkers and other patient outcomes in individuals with COVID-19. The trial is sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group, the company said.

Separately, generic pharma company Hikma Pharmaceuticals announced its wholly-owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received FDA approval for its generic equivalent to Vascepa.

In pre-market trading Friday, Amarin stock was adding 3.85% to $7.56.

Navidea Reports Positive Mid-stage Results For Rheumatoid Arthritis Treatment

Navidea Biopharmaceuticals Inc (NYSE: NAVB) announced positive preliminary results from the second interim analysis of its ongoing NAV3-31 Phase 2B study

"Analysis demonstrates that these interim data further corroborate Navidea's hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA," the company said.

The stock was seen skyrocketing 65.35% to $2.10 in pre-market trading.

Roche Buys Gene Sequencing Tech Company

Roche Holdings AG (OTC: RHHBY) announced acquisition of Stratos Genomics, an early-stage sequencing technology company to advance the development of its nanopore sequencer.

The company did not disclose the financial terms of the deal

Tetraphase Deems Melinta's Latest All-Cash Offer As Superior, Notifies AcelRx

Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH), which has been pursued by multiple companies, said its board has determined that the latest proposal from Melinta Therapeutics, Inc. is a "Superior Offer."'

Melinta has offered $27 million in cash, plus an additional $12.5 million in cash potentially payable under contingent value rights to be issued in the proposed acquisition.

View more earnings on IBB

Tetraphase, which agreed to a deal to be bought byAcelRx Pharmaceuticals Inc (NASDAQ: ACRX), said it has informed about its determination concerning the Melinta offer and given AcelRx time until May 29 to either terminate the merger or revise the terms of the merger.

Incidentally, La Jolla Pharmaceutical Company (NASDAQ: LJPC) had also tabled an offer for Tetraphase.

In pre-market trading, AcelRx shares were adding 2.74% to $1.50.

Amag Divests Intrarosa For Upto $125M

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) said it has completed the sale of its rights to Intrarosa to Millicent Pharma Limited, for up to $125 million, including upfront fixed consideration of $20 million and contingent, sales-based milestone payments of up to $105 million.

The company said the sale is consistent with its previously announced strategic decision to divest its women's health assets. It also said it remains committed to the divestiture of Vyleesi and associated expense reductions as previously announced.

Offerings

ContraFect Corp Stock (NASDAQ: CFRX) said it has priced its underwritten public offering of 11.8 million shares of its common stock and related warrants to purchase 8.85 million shares. The gross proceeds from the public offering will be approximately $52.5 million, it said. All shares in the public offering are to be sold by ContraFect.

In premarket trading Friday, the stock was slipping 11.87% to $4.75.

Hoth Therapeutics Inc (NASDAQ: HOTH) priced its underwritten public offering of 1.82 million shares of common stock at $2.75 per share, for raising gross proceeds of $5 million. The offering is expected to close on or about May 27.

The stock was slipping 5.36% to $3 in premarket trading Friday.

Dynavax Technologies Corporation (NASDAQ: DVAX) priced its previously announced underwritten public offering of 14 million shares of its common stock at $5 per share. The gross proceeds to Dynavax from the offering are expected to be approximately $70. The offering is expected to close on or about May 27.

The stock was retreating 10.25% to $5.08 in premarket trading Friday.

PPD Inc (NASDAQ: PPD) said it upsized and finalized the terms of the offering of $500 million aggregate principal amount of 4.625% senior notes due 2025 and $700 million aggregate principal amount 5.000% senior notes due 2028. The aggregate principal amount of the notes to be issued in the offering was increased to $1.2 billion from the previously announced $700 million, the company said.

In premarket trading Friday, the stock was adding 1.23% to $28.

Geron Corporation (NASDAQ: GERN) said it intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of its common stock in an underwritten public offering. All the securities earmarked for the offering are being sold by the company.

The stock was slipping 20.92% to $1.55 in pre-market trading.

On The Radar Clinical Readouts

Atara Biotherapeutics Inc's (NASDAQ: ATRA) abstract on the Phase 1 data for ATA188 in multiple sclerosis, regarding its European Academy for Neurology presentation, will be made available online at 12:30 pm ET.

Earnings

Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)

IPO

Inari Medical, a medical device company, priced its upsized initial public offering of 8.203 million shares of its common stock at $19.00 per share, for total gross proceeds of approximately $156 million. The company had earlier planned for a 7.33-million stock offering, with an estimated price of $17-$18 per share. The shares are to be listed on the Nasdaq under the ticker symbol NARI.

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