Today’s Daily Dose brings you news about BioCryst’s update on its investigational broad-spectrum antiviral Galidesivir in the treatment of COVID-19, a $7 million strategic investment by Acorn Bioventures in Cyclacel Pharma, Supernus’ phase III study results of SPN-812 in adults for the treatment of attention deficit hyperactivity disorder, and Spectrum’s progress with Poziotinib for non-small cell lung cancer.
1. BioCryst Not to Pursue COVID-19 indication for antiviral Galidesivir
Shares of BioCryst Pharmaceuticals Inc. (BCRX) dropped more than 8% on Tuesday after the company announced that it will no longer be pursuing the COVID-19 indication for its investigational broad-spectrum antiviral Galidesivir.
The company also announced data from part 1 of a clinical trial of Galidesivir, which showed the compound to be safe and generally well tolerated in patients infected with SARS-CoV-2, the virus that causes COVID-19. However, the trial was not designed or sized to demonstrate clinical efficacy and no clinical efficacy benefit with Galidesivir treatment compared to placebo treatment was observed in the trial.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the development of Galidesivir. The company expects NIAID to continue their support to explore the potential of Galidesivir in addressing biodefense threats, such as Marburg virus disease.
BCRX closed Tuesday’s trading at $7.59, down 8.55%. In after-hours, the stock fell another 2.37% and was at $7.41.
2. Cyclacel Gets Strategic Investment from Acorn Bioventures
Cyclacel Pharmaceuticals Inc. (CYCC) has entered into a definitive securities purchase agreement with Acorn Bioventures, LP, a biotech-focused fundamental investor, enabling clinical development of its two internally-discovered molecules, Fadraciclib and CYC140, in hematological malignancies and solid tumors.
As per the agreement, Acorn Bioventures has agreed to purchase in a registered direct offering 485,912 shares of common stock and 237,745 shares of newly designated Series B Preferred Stock, and in a concurrent private placement, warrants to purchase 669,854 shares of common stock, for aggregate gross proceeds of approximately $7 million. The warrants will be exercisable beginning twelve months following the date of issuance, will expire on the five-year anniversary of the date of issuance, and have an exercise price of $4.13 per share.
CYCC closed Tuesday’s trading at $6.40, up 49.53%.
3. Supernus Gets The Much-needed Attention
Supernus Pharmaceuticals Inc.’s (SUPN) phase III study of SPN-812 in adults for the treatment of attention deficit hyperactivity disorder has yielded positive topline results.
At a daily dose of up to 600mg of SPN-812, the trial met the primary endpoint showing efficacy on both hyperactivity/impulsivity and inattention subscales with statistical significance compared to placebo. The study also met the key secondary efficacy endpoint with statistical significance in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week 6.
SPN-812, proposed for the treatment of ADHD in pediatric patients 6 to 17 years of age, was issued a Complete Response Letter by the FDA last month. The company will be meeting with the FDA in January 2021 to discuss the Complete Response Letter.
SUPN closed Tuesday’s trading at $22.52, up 0.45%. In after-hours, the stock was up nearly 25% at $27.99.
4. Spectrum to Submit Poziotinib NDA Next Year
Spectrum Pharmaceuticals Inc. (SPPI) is planning to submit its New Drug Application for Poziotinib for non-small cell lung cancer in previously treated patients with HER2 exon 20 insertion mutations next year.
The data from Cohort 2 of the company’s phase II clinical trial, ZENITH20, which evaluated an oral once daily dose of 16 mg of Poziotinib in previously treated patients with non-small cell lung cancer with HER2 exon 20 insertion mutations will serve as the basis for NDA submission. This Cohort had enrolled 90 patients and has demonstrated a confirmed objective response rate (ORR) of 27.8%
The pre-specified primary endpoint of ORR was not met in Cohort 3, which had enrolled a total of 79 patients who received an oral once daily dose of 16 mg of Poziotinib.
SPPI closed Tuesday’s trading at $4.25, down 2.97%.
5. Soligenix Plunges on DOM-INNATE Data
Shares of Soligenix Inc. (SNGX) plunged to a new low on Tuesday, following disappointing results from a phase III trial of SGX942 for the treatment of Oral Mucositis in head and neck cancer patients.
The trial, dubbed DOM-INNATE, which had enrolled 268 patient, did not achieve statistical significance in the primary endpoint of median duration of severe oral mucositis. However, biological activity was observed with a 56% reduction in the median duration of severe oral mucositis from 18 days in the placebo group to 8 days in the SGX942 treatment group.
Commenting on the study results, Christopher J. Schaber, President and Chief Executive Officer of Soligenix, said, “Despite the fact that SGX942 demonstrated clinically meaningful reductions in oral mucositis consistent with the phase II study, the phase III trial did not achieve the statistically significant benefit we expected. Over the coming weeks, we will be analyzing the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from SGX942 therapy, we will certainly communicate our findings and explore follow-up discussions with the FDA and EMA”.
SNGX closed Tuesday’s trading at $1.39, down 49.27%.
6. Stocks That Hit New Highs/Lows
Sigilon Therapeutics, Inc. (SGTX) closed Tuesday’s trading at a new high of $45.35, up 9.17%.
Spero Therapeutics Inc. (SPRO) closed at an all-time high of $21.75, up 14.47%.
Beam Therapeutics Inc. (BEAM) closed at an all-time high of $88.52, down 0.70%.
Venus Concept Inc. (VERO) closed at an all-time low of $1.89, down 25.59%.
Soligenix Inc. (SNGX) closed at an all-time low of $1.39, down 49.27%.
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