Avanir Pharmaceuticals, IncNASDAQ
Wed, Jan. 20, 9:04 AM| Wed, Jan. 20, 9:04 AM
Nov. 27, 2015, 10:43 AM
- The FDA's Psychopharmacologic Drugs Advisory Committee will meet on Tuesday, December 1, to review privately held Fabre-Kramer Pharmaceuticals' New Drug Application (NDA) for gepirone hydrochloride extended-release tablets for the treatment of major depressive disorder (MDD).
- FDA briefing doc
- Company briefing doc
- Draft questions
- MDD-related tickers: (OTCQB:VSTA)(OTCPK:OTSKY)(OTCPK:TKPYY)(NYSE:PFE)(NASDAQ:ALKS)(NASDAQ:AVNR)(NYSE:TEVA)(NASDAQ:SHPG)(NYSE:LLY)(NYSE:GSK)
Apr. 24, 2015, 3:52 PM
- Burlington, MA-based CoLucid Pharmaceuticals (Pending:CLCD) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The clinical stage biopharmaceutical firm is developing a small molecule for the acute treatment of migraine headaches. Lasmiditan, currently in Phase 3 development in an oral tablet form, is a 5-HT1F receptor agonist that blocks the pain transmission without the side effects of the class of migraine therapies called triptans. The 5-HT1F receptor is a serotonin subtype that lacks the vasoconstrictive properties of other serotonin receptors, which can cause adverse cardiac events in patients with cardiovascular or cerebrovascular disease. Top-line data from a Phase 3 study, called SAMURAI, is expected in Q3 2016. A second Phase 3 evaluating an IV formulation of lasmiditan should commence in H1 2016.
- The company licensed lasmiditan from Eli Lilly.
- 2014 financials ($M): Operating expenses: 2.3 (+43.8%); Net Loss: (3.0) (-34.6%); CF Ops: (0.8) (+49.3%).
- Migraine-related tickers: (OFIX +0.4%)(TEVA +1.8%)(AVNR)(RDHL +0.5%)(PTX -3%)(ALDR -0.8%)(ENDP -0.8%)(JNJ +0.6%)(AMGN -0.7%)(DEPO +1.2%)(AGN)
Dec. 2, 2014, 9:12 AM
Dec. 2, 2014, 7:18 AM
Dec. 2, 2014, 3:44 AM
- Deal values Avanir (NASDAQ:AVNR) at $3.5B.
- Otsuka (OTCPK:OTSKY) will launch a tender offer within ten business days to purchase all outstanding shares of Avanir and will end 20 days later.
- Expected to close in the first quarter of 2015.
- Management: "As we bring together Otsuka's experience and business track record in the area of mental illnesses with Avanir's strengths in neurologic diseases, we believe that we can evolve into a truly global CNS pharmaceutical company. Avanir's creativity and proven execution on drug discovery and development for largely unexplored medical indications, typified by PBA, represents a hand-in-glove fit with Otsuka's culture. We admire and respect Avanir's innovation, vision, and execution and want to continue to grow together."
- Avanir closed yesterday at $15.
- Previously: Avanir moves up on takeout speculation
- Previously: Avanir skyrockets premarket on trial results
Nov. 28, 2014, 7:59 AM
- As expected, Avanir Pharmaceuticals (NASDAQ:AVNR) receives a Complete Response Letter (CRL) from the FDA related to its New Drug Application (NDA) for AVP-825, an investigational drug-device combination for the treatment of migraines.
- Consistent with previous feedback, the agency requests that Avanir assess the root cause (s) of device use errors observed in the previously conducted human factors testing. A new validation study to assess the device's usability following improvements to the product will be required. The FDA did not specify any additional trials that need to be conducted prior to approval.
- Avanir Chief Medical Officer Joao Siffert, M.D., says, "We believe the concerns raised by the FDA are fully addressable. Following the receipt of the preliminary feedback we have been working internally and with the FDA toward implementing changes prior to repeating the human factors study. Based on these conversations, we will conduct a new human factors study, with input from the FDA, with a goal to respond to the CRL in the first half of calendar 2015."
- Previously: FDA approval unlikely as PDUFA date approaches for Avanir
Nov. 21, 2014, 10:46 AM
- November 26 is the PDUFA date for the FDA's decision on Avanir Pharmaceuticals' (AVNR +0.9%) NDA for AVP-825, its investigational drug-device combination for the acute treatment of migraines. Approval is unlikely, though. Earlier this month, the agency issued preliminary written feedback to the company where it questioned the human factor validation data in the submission.
- The FDA submitted its feedback via a Discipline Review Letter, which it employs to convey its preliminary opinion on possible deficiencies in an application. In the letter, the regulator requested that Avanir optimize the product-user interface and conduct additional human factor testing. Also, it stated that its review of the NDA was incomplete and it may have additional comments concerning the submission.
- Human factor testing focuses on the interactions between people and devices. The goal in testing is the evaluate use-related risks and to confirm that patients can use the device safely and effectively.
- Previously: Successful Phase 3 results for Avanir migraine product
Nov. 7, 2014, 9:14 AM
- Gainers: MITK +29%. RMTI +27%. RPRX +24%. SHLD +22%. CNET +15%. NETE +11%. PGNX +10%. ZNGA +9%. APT +9%. KING +9%. KING +9%. KGC +8%. TKMR +7%. AGIO +7%. BEBE +5%.
- Losers: SLXP -35%. MDRX -20%. CTIC -19%. ICPT -19%. UBNT -17%. ANF -13%. ANET -11%. ORBC -10%. AVNR -7%. FSLR -7%. PLNR -6%. NDLS -6%. RIG -5%. DVA -5%. NADL -5%.
Nov. 5, 2014, 8:11 AM| Nov. 5, 2014, 8:11 AM | 1 Comment
Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Oct. 13, 2014, 5:34 PM
- As previously reported, Avanir Pharmaceuticals (AVNR +2.4%) presented data from its Phase 2 clinical trial evaluating AVP-923 for the treatment of agitation in patients with Alzheimer's disease at a poster session today at the American Neurological Association Meeting.
- The results showed a clinically meaningful and statistically significant improvement in agitation scores. The study achieved its primary endpoint of a statistically significant benefit on the agitation/aggression domain of the Neuropsychiatric Inventory (NPI) (p=0.00008). The NPI agitation/aggression score was reduced 3.3 points from baseline in treated patients at week 5 (stage 1; p=0.0002 vs placebo) and was reduced by 2.0 points in stage 2 (p=0.021).
- The change in NPI agitation/aggression score corresponds to a mean reduction from baseline of 47% for AVP-923 compared to 22% for placebo in Stage 1 and 26% vs 6.7%, respectively in Stage 2.
- AVP-923 is a combination of two well-characterized compounds, dextromethorphan hydrobromide, the active CNS ingredient, and quinidine sulfate which increases the bioavailability of the other.
- AVNR shares are down 2% AH on average volume.
Oct. 7, 2014, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
Oct. 7, 2014, 8:33 AM
- Danish biopharmaceutical firm Forward Pharma A/S (NASDAQ:FWP) is set for an IPO of 9.5M American Depository Shares at $20 - 22.
- Its lead product is FP187, a proprietary formulation of dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS), about to enter Phase 3 development.
- Meaningful revenues appear far in the distance, however. Patient recruitment for FP187's Phase 3 trial will take at least 18 months and the completion of the last patient's 48-week treatment will take a total of 30 months.
- The firm's operating losses for 2013 and 1H 2014 were $9M and $7.4M, respectively.
- MS-related tickers: (NASDAQ:BIIB) (NYSE:ABBV) (NYSEMKT:SYN) (NASDAQ:CNCE) (NYSE:SNY) (NASDAQ:XNPT) (NASDAQ:INO) (NASDAQ:OPXA) (NYSE:TEVA) (NASDAQ:ALKS) (NASDAQ:RCPT) (NASDAQ:AVNR) (NASDAQ:GCVRZ) (NYSE:NVS) (NASDAQ:QCOR)
Sep. 23, 2014, 9:10 AM
Sep. 22, 2014, 5:35 PM