- Centogene (NASDAQ:CNTG) reports Q3 results:
- Revenues increased 212% Y/Y to €36.3M, driven by the continued expansion of its COVID-19 testing offering.
- Pharma revenues decreased 21%, while Clinical Diagnostics revenues (excl. COVID) decreased 25% compared to Q3 2019.
- Commercial COVID-19 testing contributed €27.4M in revenues in the quarter, up from €2.1M in Q2 2020.
- Cash flow used in operating activities of -€19.67M.
- Cash & cash equivalents of €28.8M.
- Segment adjusted EBITDA of €9.18M vs. €4.16M a year ago.
- FY20 guidance: Revenues guidance from €80M to greater than €100M.
- Update on corporate progress: Continues growth of new pharma partnerships, with 12 new deals signed and a robust recovery anticipated in 2021.
- During the quarter appointed, Dr. Andrin Oswald as Chief Executive Officer to support the next stage of the Company’s growth.
- Previously: Centogene reports Q3 results (Dec.16).
- https://seekingalpha.com/news/3644790-centogene-jumps-8-after-q3-top-line-up-212-raises-fy20-guidance
- BioCryst Pharmaceuticals' (NASDAQ:BCRX) oral, once-daily ORLADEYO (berotralstat) is now available for shipment to patients with a prescription in the U.S.
- ORLADEYO was approved by the FDA on December 3, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
- Optime Care, the exclusive specialty pharmacy provider has begun shipping today.
- https://seekingalpha.com/news/3644797-biocrysts-orladeyo-now-available-in-u-s
- Merck (NYSE:MRK) and Eisai (OTCPK:ESALF) have announced data demonstrating positive top-line results from Phase 3 KEYNOTE-775/Study 309, evaluating Merck's Keytruda plus Eisai's Lenvima in patients with advanced endometrial cancer following at least one prior platinum-based regimen.
- The study met its primary and secondary endpoints, and demonstrated a statistically significant and clinically meaningful improvement in overall survival, progression-free survival and objective response rate versus chemotherapy (treatment of physician’s choice of doxorubicin or paclitaxel).
- Safety profile of drug combination was consistent with previously reported studies.
- Merck and Eisai will discuss these data with regulatory authorities, with the intent to submit marketing authorization applications, and plan to present these results at an upcoming medical meeting.
- Earlier today, BioLineRx's motixafortide and Keytruda combination trial reported median OS of 6.5 months compared to historical data of 4.7 months in pancreatic cancer.
- Last month, both the companies also announced that Keytruda plus Lenvima combination met endpoints in advanced renal cell carcinoma study.
- https://seekingalpha.com/news/3644799-merck-eisais-keytruda-and-lenvima-combo-meet-endpoints-in-late-stage-uterine-cancer-study
- The Lancet has published Biohaven Pharmaceutical's (NYSE:BHVN) positive results from a Phase 3 clinical trial of rimegepant for the preventive treatment of migraine in adults.
- These data show rimegepant was superior to placebo on the primary endpoint of change in mean number of migraine days.
- Rimegepant showed a −4.3 day reduction in monthly migraine days during the prespecified treatment period.
- Rimegepant was also superior to placebo on multiple secondary endpoints. Notably, 49% of the rimegepant group had at least a 50% reduction from baseline in mean number of moderate to severe migraine days per month compared to 41% in the placebo group in weeks 9 through 12.
- Additionally, the incidence of adverse events was similar with rimegepant and placebo (36% vs 36%).
- The FDA has accepted Biohaven's sNDA for NURTEC ODT for migraine prevention with PDUFA goal date in 2Q2021.
- Rimegepant is the first and only CGRP targeting medication in development to show dual efficacy for both the acute and preventive treatment of migraine.
- The Lancet full article is available online.
- https://seekingalpha.com/news/3644824-biohavens-rimegepant-effective-in-migraine-prevention
- Integra LifeSciences (NASDAQ:IART) has agreed to acquire ACell, a regenerative medicine company with a product portfolio based on porcine urinary bladder matrix platform technology, MatriStem UBM. The acquisition will help the expansion of Integra’s Orthopedics and Tissue Technologies segment.
- Deal value includes an upfront cash payment of $300M, and up to an additional $100M upon the achievement of certain revenue growth milestones.
- The transaction is expected to close in Q1 of 2021.
- ACell’s products include MicroMatrix, a particulate formulation, as well as Cytal Wound Matrix and Gentrix Surgical Matrix, both sheet formulations for the management of acute and chronic wounds and reinforcement of soft tissue in certain surgical applications.
- In 2019, ACell generated revenues of $100.8M, +13% Y/Y. Integra expects this transaction to be accretive to revenue growth and adjusted gross margins.
- Integra will host a conference call today at 9AM E.T. to provide more information regarding the acquisition.
- Earlier this year, ACell filed a preliminary prospectus for an $86M IPO.
- https://seekingalpha.com/news/3644840-integra-lifesciences-expands-regenerative-capabilities-acell-acquisition
