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 Sept. 11)
Ardelyx Inc (NASDAQ: ARDX)
Avedro Inc (NASDAQ: AVDR)
Celgene Corporation (NASDAQ: CELG)
Eidos Therapeutics Inc (NASDAQ: EIDX)
Enlivex Therapeutics Ltd (NASDAQ: ENLV)
The Medicines Company (NASDAQ: MDCO)
Medtronic PLC (NYSE: MDT)
Nevro Corp (NYSE: NVRO)
Radius Health Inc (NASDAQ: RDUS)
ZEALAND PHARMA/S ADR (NASDAQ: ZEAL)
Zimmer Biomet Holdings Inc (NYSE: ZBH)
Down In The Dumps
(Biotech stocks hitting 52-week lows on Sept. 11)
CELYAD SA/ADR (NASDAQ: CYAD)
Endologix, Inc. (NASDAQ: ELGX)
Myovant Sciences Ltd (NYSE: MYOV)
HTG Molecular Diagnostics Inc (NASDAQ: HTGM)
Karuna Therapeutics Inc (NASDAQ: KRTX)
Mersana Therapeutics Inc (NASDAQ: MRSN)
Stealth BioTherapeutics Corp (NASDAQ: MITO)
Titan Pharmaceuticals, Inc. common stock (NASDAQ: TTNP)(filed for a $12 million secondary offering)
Trinity Biotech plc (NASDAQ: TRIB)
Stocks In Focus Ardelyx Gets FDA Nod For Constipation Drug
Ardelyx announced the FDA has approved its tenapanor, brand name Ibsrela, a 50mg twice-daily oral pill for the treatment of irritable bowel syndrome with constipation in adults. The drug acts locally in the gastrointestinal tract by inhibiting the sodium-hydrogen exchanger, leading to increased bowel movements and decreased abdominal pain.
The stock fell 6.37% to $5.88 in after-hours trading.
Ritter's Lactose Intolerance Drug Fails In Late-Stage Study
Ritter Pharmaceuticals Inc (NASDAQ: RTTR) announced the Phase 3 trial of RP-G28 that is being evaluated for lactose intolerance failed to show statistical significance in its pre-specified primary endpoint. Top-line data from the 557-subject Phase 3 trial showed the investigational compound brought about a significant symptom improvement in patients, but there was no or little difference compared to placebo.
"We are continuing to analyze the results of the trial to better understand the data and clinical outcomes to assess a path forward, which may include alternative strategic options for the Company," said CEO Andrew Ritter.
The stock plummeted 72.23% to 30 cents in after-hours trading.
Celgene Aces Late-Stage Blood Cancer Study
Celgene announced top-line results from the Phase 3 Quazar AML-001 study that evaluated the efficacy and safety of its investigational therapy CD-486 as maintenance therapy in patients with newly diagnosed acute myeloid leukemia, with the study showing a highly statistically significant and clinically meaningful improvement in overall survival compared to placebo. The candidate also showed statistically significant improvement in the secondary endpoint of relapse-free survival.
The company said it plans regulatory submissions, beginning in the first half of 2020.
Eidos Board Rejects Parent BridgeBio's Buyout Offer
Eidos Therapeutics Inc (NASDAQ: EIDX) said the Special Committee of its board unanimously rejected the non-binding proposal from BridgeBio Pharma Inc (NASDAQ: BBIO), the parent entity of its majority stockholder, to purchase all outstanding shares not already owned by BridgeBio for a fixed exchange ratio of 1.30 shares of BridgeBio for each Eidos share.
The committee concluded that the proposal is inadequate and not in the best interests of Eidos' minority stockholders.
Roche's New Fixed-Dose Breast Cancer Treatment Combo Administered Subcutaneously Found Non-inferior To IV Formulation
Roche Holdings AG Basel ADR (OTC: RHHBY) said the Phase 3 FeDeriCa study that evaluated a new investigational fixed-dose combination of Perjeta and Herceptin, administered subcutaneously as injection in combination with intravenous chemotherapy showed non-inferior levels of Perjeta in blood compared to standard intervenous infusion of Perjeta plus Herceptin and chemotherapy in patients with HER2-positive early breast cancer.
"With this single injection under the skin, people with HER2-positive breast cancer receiving Perjeta and Herceptin can have a faster treatment option," said Sandra Horning, Roche's Chief Medical Officer.
The subcutaneous administration was done with Halozyme Therapeutics, Inc. (NASDAQ: HALO)'s drug delivery technology in combination with intravenous chemotherapy.
Atara's Multiple Sclerosis Treatment Found Safe And Effective In Early-Stage Study
Atara Biotherapeutics Inc (NASDAQ: ATRA) announced initial Phase 1 data for ATA 188 in multiple sclerosis at the 35th Congress of the European Committee For Treatment and Research In Multiple Sclerosis, or ECTRIMS, held in Barcelona, Spain. The off-the shelf, allogenic T-cell immunotherapy that targets the Epstein-Barr Virus-infected B cells, which is believed to play a role in the pathogenesis of multiple sclerosis, was found to have efficacy as well as a well-tolerated safety profile.
Achieve Life Sciences Smoking Cessation Drug Effective
Detailed results from Achieve Life Sciences Inc (NASDAQ: ACHV)'s Phase 2b study, dubbed ORCA-1, of cytisinicline in smoking cessation, showed that the 3mg TID treatment arm showed a 54% abstinence rate at Week 4 compared to 16% for placebo and a 4-week continuous abstinence rate, weeks 5 through 8, of 30% compared to 8% for placebo.
The company noted that continuous abstinence for 4 weeks is the relevant endpoint for regulatory approval.
Achieve shares were rising 4.59% to $2.28 in pre-market trading, Friday.
The data is to be presented at the Society for Research in Nicotine and Tobacco, Europe, 10th Annual Conference, being held in Oslo, Norway.
Catalyst Cancels Plan to Offer Common Shares
Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) said it will not go ahead with the common stock offering it announced Wednesday. The company attributed the decision to its view that the culmination of an offering at the current market price of the stock is not in the best interest of the company and its shareholders.
The stock was seen adding 11.75% to $6.85 in pre-market trading.
On The Radar Adcom Meeting
FDA's Allergenic Products Advisory Committee is scheduled to meet to discuss and make recommendations on the safety and efficacy of Aimmune Therapeutics Inc (NASDAQ: AIMT)'s AR101 indicated for the treatment to reduce the risk of anaphylaxis after accidental exposure to peanut in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy.
Clinical Trial Readouts
Novartis AG (NYSE: NVS) and Genmab is scheduled to present already released Phase 3 data for OMB158 in relapsing multiple sclerosis at the ECTRIMS Congress.
GENMAB A/S/S ADR (NASDAQ: GMAB) will present Phase 3 data for OMB157 in relapsing multiple sclerosis at the ECTRIMS Congress.
SpringWorks Therapeutics, a developer of small-molecule therapies for rare cancers, priced its upsized IPO of 9-million shares at $18, the upper bound of the estimated price range of $16-$18. The shares will begin trading on the Nasdaq under the ticker symbol SWTX.
Satsuma Pharmaceuticals, which is developing, a fast-acting dry powder nasal spray for migraines, upsized its previously announced IPO to 5.5 million shares, and priced the offering at $15, the midpoint of the estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol STSA.
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