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The Daily Biotech Pulse: AtriCure's Guidance, Guardant Health And Kodiak To Debut

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 on Oct. 3)

  • AstraZeneca plc (NYSE: AZN)
  • Bausch Health Companies Inc (NYSE: BHC)
  • Eli Lilly And Co (NYSE: LLY)
  • Merck & Co., Inc. (NYSE: MRK)
  • Pfizer Inc. (NYSE: PFE)
  • Trevena Inc (NASDAQ: TRVN)
  • Urovant Sciences Ltd. (Nasdaq: UROV)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 3)

  • CELYAD SA/ADR (NASDAQ: CYAD)
  • Entasis Therapeutics (NASDAQ: ETTX)
  • GTx, Inc. (NASDAQ: GTXI)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA)
  • Magenta Therapeutics Inc (NASDAQ: MGTA)
  • Novelion Therapeutics Inc (NASDAQ: NVLN)
  • REALM THERAPEUTICS ADR (NASDAQ: RLM)

See Also: Attention Biotech Investors: Mark Your Calendar For These October PDUFA Dates

Stocks In Focus ArtiCure Sees Q3 Revenues Above Consensus, To Offer Shares

AtriCure Inc. (NASDAQ: ATRC) released preliminary third-quarter results, expecting revenues of $49.9 million, ahead of the $46.76 million consensus estimate. U.S. revenues is expected at $39.8 million, up 19.1 percent, and international revenues is estimated to grow 16.2 percent to $10.2 million.

Separately, the company said it has commenced an underwritten public offering of 2.5 million shares of its common stock, pursuant to its existing shelf-registration statement.

The stock fell 2.46 percent to $32.86 in after-hours trading.

J&J Unit Janssen Says 96-week Extension Study Reinforces Efficacy, Saftey Of HIV Cocktail

Johnson & Johnson (NYSE: JNJ)'s Janssen unit released new 96-week data for its HIV cocktail Symtuza - darunavir 200 mg, cobicistat 150 mg, emtricitabine 200mg, and tenofovir alafenamide 10 mg –, which showed high virologic suppression, low cumulative virologic rebound and no resistant development. The combo drug is being evaluated in a Phase 3 EMERALD study in adults with HIV-1, who are virologically suppressed.

The 96-week extension study reinforced the long-term efficacy, resistance and safety profile of Symtuza, the company said.

Symtuza was approved by the European Commission in Sept. 2017 and the FDA in July 2018.

Acasti To Offer Shares Both In U.S. And Canada

Acasti Pharma Inc (NASDAQ: ACST) announced its intention to offer and sell its common shares in an underwritten public offering in the U.S. All the shares are to be offered by the company. The company said it intends to use the net proceeds for funding its TRILOGY Phase 3 program, to advance partnering discussions and for working capital and general corporate purposes.

Separately, the company commenced a separate and concurrent public offering in Canada.

The U.S.-listed shares slumped 11.48 percent to $1.08 in after-hours trading.

Sarepta Reports Positive Updated Data For Duchenne Muscular Dystrophy Candidate

Sarepta Therapeutics Inc (NASDAQ: SRPT) presented at the 23rd International Congress of the World Muscle Society in Mendoza, Argentina, positive updated results from its gene therapy clinical trial that assessed AAVrh74.MHCK7.micro-Dystrophin in individuals with Duchenne muscular dystrophy, or DMD.

View more earnings on IBB

All the four patients enrolled in the study showed robust expression of transduced micro-dystrophin, which is properly localized to the muscle sarcolemma.

The stock gained 2.46 percent to $151 in after-hours trading.

Roche's Flu Drug Produces Positive Results In Late-stage Trial

Roche Holdings AG Basel ADR (OTC: RHHBY) announced that Phase III CAPSTONE-2 study that evaluated its baloxavir marboxil showed that the treatment candidate significantly reduced the time to improve influenza symptoms versus placebo, with a median time of 73.2 hours for the pipeline asset versus 102.3 hours for the placebo, in people at high risk of serious complications from the flu.

"This is the first phase III trial to demonstrate a significant, clinically meaningful benefit in people at high-risk for complications from the flu for which there are no currently approved medicines." said Sandra Horning, Roche's Chief Medical Officer.

On The Radar

PDUFA Dates

Roche's Genentech unit awaits FDA nod for an expanded indication for its Hemlibra. Hemlibra has already been approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitor. This time around the company is seeking clearance for treating adults and children with haemophilia A without factor VIII inhibitors.

IPO

Guardant Health, which develops non-invasive blood-based cancer diagnostics tests, priced its initial public offering of 12.5 million at $19, above the estimated price range of $15 to $17. The shares are to be listed on the Nasdaq under the ticker symbol GH.

Kodiak Sciences priced its 9-million share initial public offering at $10 per share, below the estimated price range of $13-$15 in an IPO. The company, which develops anti-VEGF inhibitors for wet AMD, is to list the shares on the Nasdaq under the ticker symbol KOD.

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