- Affimed (AFMD +10.3%) Q3 results:
- Revenue of €10.6M (+402.4% Y/Y).
- Operating Loss: (€2.9M) (+76.6%); Net Loss: (€6.0M) (+44.9%); Loss Per Share: (€0.07) (+58.8%).
- Quick Assets: €97.3M, with anticipated cash runway into 1H of 2023.
- Upcoming milestones: AFM13 pTCL REDIRECT monotherapy study's interim analysis expected during 1H of 2021.
- The initiation of the Phase 1 study of drug RO7297089 in patients with relapsed or refractory multiple Myeloma with Genentech triggered a milestone payment recognized in the 3Q.
https://seekingalpha.com/news/3634396-affimed-jumped-10-after-q3-beat-robust-growth-in-top-line-of-402
Tuesday, November 10, 2020
Affimed jumps after Q3 beat, robust growth in top-line of 402%
Atossa's COVID-19 nasal spray 'safe' in early-stage study
- tossa Therapeutics (ATOS +3.1%) has announced blinded preliminary results from Phase 1 study evaluating AT-301 administered by nasal spray, for the treatment of COVID-19.
- AT-301 under development for at home use, was found to be safe and well tolerated at two different dose levels in both single and multiple dose forms over 14 days.
- There we no serious adverse events, no discontinuations, and only one subject of the 32 subjects experienced moderate adverse events and all other adverse events were mild in intensity.
- The company is preparing for a pre-IND meeting request with the FDA, planned to be submitted in the next 30 days.
- Atossa also plans to develop its nasal spray to potentially help prevent COVID-19 infection.
- In September, the investigational med received second positive safety review.
- https://seekingalpha.com/news/3634385-atossas-covidminus-19-nasal-spray-safe-in-early-stage-study
Praxis Precision Medicine plummets on clinical hold on lead drug
- Recent IPO Praxis Precision Medicines (PRAX -27.0%) craters on average volume in reaction to the FDA's clinical hold on its Investigational New Drug (IND) application for lead candidate PRAX-114, an extrasynaptic-preferring GABAa receptor positive allosteric modulator, for the potential treatment of major depressive disorder (MDD) and perimenopausal depression.
- The company says the agency has not explained the reason for the hold, which prohibits the start of its planned Phase 2/3 clinical trial in MDD, only saying that its comments have yet to be finalized.
- https://seekingalpha.com/news/3634401-praxis-precision-medicine-plummets-27-on-clinical-hold-on-lead-drug
Arcturus expects its COVID-19 vaccine to be ready by first-quarter 2021
U.S. biotech firm Arcturus Therapeutics said it expects to start distributing its COVID-19 vaccine candidate in the first quarter of next year after early stage trials showed promising results.
The firm said in a statement on Monday it had struck supply deals with Israel and Singapore - where it is working on the vaccine with a university and has been conducting trials - and was urgently working to start later stage trials.
The California-based company’s announcement came as Pfizer said its COVID-19 vaccine is more than 90% effective based on initial trial results, a major victory in the war against a virus that has killed over a million people and battered the world’s economy.
The news from Pfizer, which could pave the way for its vaccine to be rolled out by year end, weighed sharply on the shares of Arcturus, which closed down 45%, and other smaller vaccine developers.
Arcturus added in its statement that its ARCT-021 candidate has been generally well tolerated in trials so far.
Equity analysts at Laidlaw & Company attributed the weakness in Arcturus’ stock to concern that the efficacy of ARCT-021 might not be as robust as other competitors, while Roth Capital Partners said its results showed a continually improving immune response. Both firms have a buy rating on the stock.
Elsewhere, Inovio Pharmaceuticals and Sorrento Therapeutics closed down 19% and 17%, respectively.
BioNTech to price vaccine below market rates, differentiate between regions
BioNTech, first in the race to produce evidence of a working COVID-19 vaccine, is planning to price the two-shot regimen below “typical market rates” and would differentiate pricing between countries or regions.
Speaking at a Financial Times online event, the German biotech firm’s strategy head Ryan Richardson said the price tag of the vaccine, which is co-developed with Pfizer and which has yet to win regulatory approval, would reflect the financial risks that its private-sector investors have incurred.
“We’ve tried to pursue a balanced approach that recognises that innovation requires capital and investment so we plan to price our vaccine well below typical market rates reflecting the situation that we’re in and with the goal to insure broad-based access around the world,” Richardson said at the FT event.
“I expect there to be differential pricing in certain regions of the world,” he added, declining to elaborate on the different price tags.
Lilly gets emergency OK for COVID-19 treatment bamlanivimab
- Eli Lilly (NYSE:LLY) has received emergency use authorization from the FDA for bamlanivimab, a treatment for mild-to-moderate COVID-19 in adult and pediatric patients.
- Lilly says it will begin shipping the treatment immediately to AmerisourceBergen (NYSE:ABC), which will distribute it as directed by the government's allocation program. The government will allocate 300,000 doses to high-risk patients at no out-of-pocket cost.
- Safety and effectiveness continue to be evaluated, but bamlanivimab was shown in clinical trials to reduce COVID-19 hospitalization and ER visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
- It's not authorized for patients who are hospitalized or require oxygen therapy.
https://seekingalpha.com/news/3634128-eli-lilly-gets-emergency-ok-for-covidminus-19-treatment-bamlanivimab-sharesplus-4_7
Supernus Pharma whiffs for now on NDTAs for SPN-812, SPN-830
- Supernus Pharmaceuticals (NASDAQ:SUPN) says it received a complete response letter regarding its new drug application for SPN-812 for the treatment of ADHD in pediatric patients 6-17 years old.
- The FDA says the application is not ready for approval in its present form, citing Superna's in-house laboratory that conducts analytical testing, which recently moved to a new location; no clinical safety or efficacy issues were identified.
- Superna says it will discuss with the FDA that the application does not rely solely on this facility for product release, and will discuss steps required to re-submit the NDA for SPN-812.
- The company also received a refusal to file letter from the FDA regarding its NDA for SPN-830 for the continuous treatment of motor fluctuations in Parkinson's disease, as the agency requested certain documents and reports in support of the application.
- The company also raised its operating income forecast for the full year, now guiding for $155M-$170M compared with $145M-$160M previously, while maintaining its outlook for full-year net product sales at $500M-$525M.
- Supernus last week reported better than expected Q3 earnings and revenues.
- https://seekingalpha.com/news/3634131-supernus-pharma-whiffs-for-now-on-ndas-for-spnminus-812-spnminus-830
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