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 Dec. 7)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Dec. 7)
- Lyra Therapeutics Inc (NASDAQ:LYRA) (reacted to a mid-Phase 2 readout of its LYR-210 in treating chronic rhinosinusitis with or without nasal polyps)
- Maravai Lifesciences Holdings Inc (NASDAQ:MRVI)
Stocks In Focus
ASH Presentations
Agios Pharmaceuticals Inc (NASDAQ:AGIO) announced updated data from the Phase 1 study evaluating mitapivat in adults with sickle cell disease showing, as of the data cut-off, six of 11 efficacy evaluable patients (55%) achieved a hemoglobin increase of more than1 g/dL from baseline, all at doses of 50 mg or less.
The company also noted dose-dependent increases in ATP and decreases in 2,3-DPG, as well as decreases in total bilirubin, LDH and absolute reticulocyte count. Safety profile was also consistent with previous studies, it added.
Agios said it expects to initiate a pivotal program in 2021.
Trillium Therapeutics Inc (NASDAQ:TRIL) presented at the ASH conference with updated data for TTI-622, which is being evaluated as a monotherapy in patients with advanced relapsed or refractory lymphoma. Updated data as of a Nov. 3 cut-off date showed one patient at the 12 mg/kg dose level achieved a stable disease assessment.
The company also said dosing of TTI-621 — another pipeline asset evaluated in a Phase 1 dose escalation study in relapsed or refractory hematologic malignancies — of up to 0.5 mg/kg conducted under dose-limiting toxicity criteria is complete.
The stock was down 7.18% at $14.22 premarket Tuesday.
Mean FIX activity for the three patients at two years after administration was 44.2% of normal compared to 41% of normal at 52 weeks.
The company said in a five-year follow-up Phase 1/2 study that AMT-060 gene therapy showed stable FIX expression and durable reductions in bleeding and FIX consumption.
The stock was down 4.54% to $41.80 in after-hours trading.
Axsome Reports Positive Phase 2 Results For AXS-05 In Major Depressive Disorder
Axsome Therapeutics Inc (NASDAQ:AXSM) announced positive results from the open-label Phase 2 COMET-SI trial of AXS-05 in patients with major depressive disorder who have suicidal ideation.
Patients treated with AXS-05 experienced rapid reduction of suicidal ideation, rapid functional improvement and rapid, substantial and durable improvements in overall depressive symptoms, the company said.
AXS-05 was well-tolerated in the COMET trial, it added.
BeiGene's In-Licensed Leukemia Drug Approved In China
Takeda's Swelling Disorder Drug Approved In China
Takeda Pharmaceutical Co Ltd (NYSE:TAK) said China's NMPA has approved Takhzyro subcutaneous injection for prophylaxis to prevent attacks of hereditary angioedema in patients 12 years and older.
"This milestone demonstrates Takeda's ongoing commitment to support the HAE community globally, as we work to expand access to TAKHZYRO and potentially 14 more highly innovative Takeda medicines to China's patients over the next five years," said Sean Shan, president of Takeda China.
Qiagen Raises Full-Year Guidance, Sounds Out Strong Performance In 2021
Molecular diagnostics company Qiagen NV (NYSE:QGEN) raised its full-year 2020 net sales and adjusted earnings per share growth guidance, and also guided to strong performance in 2021.
The company expects net sale growth of at least 32% for the fourth quarter and adjusted EPS of 64-65 cents in constant exchange rate. For the full-year 2020, the company expects net sales growth of 22% and adjusted EPS of $2.13-$2.14.
Offerings
Marinus Pharmaceuticals Inc (NASDAQ:MRNS) announced an underwritten public offering of its common stock. All of the shares to be sold in the offering will be offered by the company.
The stock was down 9.14% premarket at $14.21.
Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) priced an underwritten public offering of 1.365 million shares of its common stock at $110 each, for raising gross proceeds of $150 million.
The closing of the offering is expected to occur on or about Dec. 1.
The stock was down 5.79% premarket at $116.50.
Repligen Corporation (NASDAQ:RGEN) priced its underwritten public offering of 1.5 million shares at $181 per share. The offering is expected to close on or about Dec. 10, and will likely raise $271.5 million in gross proceeds.
The stock was down 0.6% to $184.80 premarket.
Syndax Pharma said it plans to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering. All the shares are to be sold by the company.
Atara announced that it has commenced an underwritten public offering of $150 million in shares of its common stock. All of the shares in the proposed offering will be sold by the company.
The stock was down 1.3% premarket at $25.89.
Sutro Biopharma Inc (NASDAQ:STRO) said it intends to offer 5 million shares of its common stock in a underwritten public offering. All of the shares of common stock are being offered by the company.
The stock ended down 3.65% to $21.10 in after-hours trading.
On The Radar
Clinical Readouts
Harpoon Therapeutics Inc (NASDAQ:HARP) is scheduled to present a clinical update for its three most advanced TriTAC programs — namely HPN424 for the treatment of metastatic castration resistant prostate cancer, HPN536 initially in development for ovarian and pancreatic cancer and mesothelioma and HPN217 for relapsed/refractory multiple myeloma.
Evelo Biosciences Inc (NASDAQ:EVLO) will present at the San Antonio Breast Cancer Symposium with a poster of additional data from a Phase 1/2 trial of EDP1503 in triple-negative breast cancer.
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
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