Ironwood Has Plenty Of Market Development Work Ahead
Stephen Simpson, CFA
Stephen Simpson, CFA
Mon, Jul. 25, 12:46 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Allergan's (AGN -0.9%) TRUBERZI (eluxadoline) for the treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).
- In two pivotal studies, patients treated with TRUBERZI experienced significant reductions in the two most bothersome IBS-D-related symptoms: abdominal pain and diarrhea, with sustained relief over six months.
- A final decision from the European Commission (EC) usually takes ~60 days.
- If approved, TRUBERZI will join Ironwood Pharmaceuticals' (IRWD -2.1%) CONSTELLA (linaclotide), approved by the EC in June 2013, as the only medications in the EU licensed to treat IBS-D symptoms.
Thu, Jun. 9, 10:47 AM
- Ironwood Pharmaceuticals (IRWD +0.3%) and U.S. commercialization partner Allergan (AGN -0.6%) announce that the FDA has accepted for review their supplemental New Drug Application (sNDA) seeking approval of a 72 mcg dose of LINZESS (linaclotide) for the treatment of chronic idiopathic constipation. The decision date should be early next year.
- LINZESS is currently approved at a dose of 145 mcg.
Mon, May 9, 4:40 PM
Mon, May 9, 4:26 PM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) Q1 results ($M): Collaborative Revenues: 66.0 (+128.3%); Operating Expenses: 68.0 (+19.3%).
- Net Loss: (13.3) (+60.0%); Non-GAAP Net Loss: (11.7) (+64.9%); Loss Per Share: (0.08) (+66.7%); Non-GAAP Loss Per Share: (0.08) (+66.7%). Consensus: Loss of 0.14 per share on revenues of $53.6M.
- LINZESS net U.S. Sales by Allergan: $137.1M (+43.6%); IRWD's portion: $46.6 (+85.6%).
- 2016 Guidance: Use of less than $70M in cash for operations, up from less than $60M before lesinurad deal with AstraZeneca. Combined (with Allergan) sales & marketing expenses to support LINZESS: $220M - 260M.
- Q2 Consensus: Loss per share of $0.16 on revenues of $53.1M.
Sun, May 8, 5:35 PM
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Tue, Apr. 26, 7:31 AM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) secures exclusive U.S. rights to AstraZeneca's (NYSE:AZN) Zurampic (lesinurad), approved by the FDA in December 2015, in combination with a xanthine oxidase inhibitor, for the treatment of hyperuricemia (excess uric acid in the blood) associated with uncontrolled gout. Lesinurad inhibits the function of transporter proteins involved in uric acid resorption in the kidneys, thereby helping them excrete uric acid.
- Under the terms of the agreement, AstraZeneca will receive an upfront payment of $100M, milestones up to $165M and tiered single-digit royalties. It will be responsible for manufacturing and supply, certain product support services, the FDA's post-approval commitment and an regulatory submission in H2 for a fixed-dose combination product.
- Ironwood expects to pay the upfront fee with cash on hand. The deal should be cash flow accretive in 2019 and beyond. Peak sales of Zurampic are expected to be ~$300M in 2022.
- Management will host a conference call this morning at 8:00 am ET to discuss the deal.
- Update: On June 3, Ironwood announced the deal closed. The transaction includes exclusive rights to the fixed dose combination of lesinurad and allopurinol. AstraZeneca plans to submit the fixed-dose combination program to the FDA for review in H2 2016 on Ironwood's behalf. The agreement also includes certain rights to potentially access RDEA3170 in gout indications in the U.S.
Fri, Apr. 8, 11:05 AM
- MacroGenics (MGNX +3.1%) initiated with Buy rating and $35 price target by BTIG Research.
- Viking Therapeutics (VKTX -39.4%) initiated with Buy rating and $6 price target by H.C. Wainwright.
- Pfizer (PFE -0.3%) initiated with an Overweight rating and $38 price target by JP Morgan.
- Medivation (MDVN -0.1%) initiated with Buy rating and $56 price target by SunTrust Robinson Humphrey.
- Eyegate Pharmaceuticals (EYEG +6.5%) initiated with Buy rating and $10 price target by Noble Financial.
- Eiger Biopharmaceuticals (EIGR +0.5%) initiated with Buy rating and $35 price target by Jefferies.
- Vertex Pharmaceuticals (VRTX +0.3%) initiated with Market Perform rating and a $90 price target by BMO Capital.
- SocGen has been busy with initiations on six large cap pharmas: Buy: Merck (MRK +0.1%); Hold: Johnson & Johnson (JNJ -0.4%), Eli Lilly (LLY -0.3%) and Pfizer; Sell: Bristol-Myers Squibb (BMY -0.4%) and AbbVie (ABBV -0.9%).
- Tokai Pharmaceuticals (TKAI -6.7%) initiated with Buy rating and $16 price target by Bank of America. Initiated with Buy rating by Janney Capital.
- Cellectis (CLLS -0.1%) initiated with Buy rating and $45 price target by Ladenburg Thalmann.
- Novartis (NVS +0.5%) initiated with Hold rating by Argus Research.
- TherapeuticsMD (TXMD) initiated with Buy rating and $10 price target by Goldman Sachs.
- Protalix (PLX -4.2%) initiated with Buy rating and $3.50 price target by Rodman & Renshaw.
- Raptor Pharmaceuticals (RPTP -0.4%) upgraded to Outperform from Market Perform by JMP Securities.
- Ironwood Pharmaceuticals (IRWD -0.6%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $16 from $12.
- Intercept Pharmaceuticals (ICPT -6%) upgraded to Outperform from Market Perform by Wells Fargo.
- Edwards Lifesciences (EW -0.1%) upgraded to Buy from Neutral with $115 price target by BTIG Research.
- Express Scripts (ESRX +0.7%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $80 from $76.
- BIND Therapeutics (BIND -7%) downgraded to Market Perform from Outperform by Cowen & Company.
- Allergan (AGN -0.5%) downgraded to Neutral from Buy by Mizuho Securities. Downgraded to Neutral from Positive by Susquehanna. Price target lowered to $275 from $345.
- Bruker (BRKR +0.2%) downgraded to Market Perform from Outperform by Leerink Swann. Price target is $27.
Tue, Apr. 5, 8:53 AM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) slumps 6.5% premarket, albeit on only 1,400 shares, in response to its announcement that it has stopped development of IW-9179 for the treatment of diabetic gastroparesis (DP) after top-line results from a 90-subject Phase 2a study failed to show a meaningful treatment benefit over and above placebo.
- The company intends to focus its efforts three key areas: irritable bowel syndrome with constipation/chronic idiopathic constipation, vascular and fibrotic disease and refractory gastroesophageal reflux disease.
- Read now Ironwood Has Plenty Of Market Development Work Ahead
Thu, Mar. 24, 4:05 PM
- Accelerate Diagnostics (AXDX +12.7%) initiated with Overweight rating and $17 (26% upside) price target by JP Morgan.
- Inogen (INGN -2.1%) initiated with Neutral rating with a $46 (15% upside) price target by Piper Jaffray.
- Incyte (INCY +3.3%) initiated with Overweight rating and $85 (21% upside) price target by Morgan Stanley.
- West Pharmaceutical Services (WST -0.1%) initiated with Outperform rating with a $69 (6% upside) price target by Wells Fargo.
- Ironwood Pharmaceuticals (IRWD +1%) initiated with Neutral rating and $14 (35% upside) price target by Goldman Sachs.
- HeartWare International (HTWR -0.4%) upgraded to Buy from Neutral by Bank of America.
- WebMD (WBMD +0.4%) upgraded to 3.5 stars from 3.0 stars (out of 5.0) by top raters at Vetr community. Price target is $62.50 (7% upside).
- Tandem Diabetes (TNDM -15.7%) downgraded to Underperform from Neutral by Bank of America.
- EndoChoice (GI -9.1%) downgraded to Underperform from Buy with a $10 price target by Bank of America.
- DENTSPLY (XRAY -1.6%) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target is $65 (9% upside).
- Novartis (NVS -0.8%) downgraded to Market Perform from Outperform by Leerink. Price target lowered to $85 (16% upside) from $98.
- Infinity Pharmaceuticals (INFI -4.3%) downgraded to Underperform from Neutral by Wedbush. Price target lowered to $3 (40% downside risk) from $8.
- Valeant Pharmaceuticals (VRX -7%) downgraded to Equal Weight with $34 (10% upside) price target by Barclays. Downgraded to Underperform from Neutral by Mizuho. Price target lowered to $18 (42% downside risk) from $70.
Wed, Feb. 24, 8:39 AM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) earns a $15M milestone payment from development and commercialization partner Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) triggered by the latter's filing of a new drug application in Japan seeking clearance of linaclotide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). The milestone was stipulated in the companies' 2009 licensing agreement for the development of the product in Japan.
- Linaclotide, marketed in the U.S. under the band name Linzess, is a guanylate cyclase-C (GCC) receptor agonist. GCC is a key receptor for enterotoxins that cause diarrhea.
Fri, Feb. 19, 7:15 AM
- Ironwood Pharmaceuticals (IRWD -1.94%) Q4 results: Revenues: $53.3M (+39.9%); R&D Expense: $27.6M (+0.4%); SG&A: $31.5M (+2.9%); Operating Loss: ($5.8M) (+82.5%); Net Loss: ($14M) (+62.8%); Loss Per Share: ($0.09) (+66.7%); Non-GAAP Loss Per Share: ($0.10) (+63.0%).
- FY2015 results: Revenues: $149.6M (+95.8%); R&D Expense: $108.7M (+6.7%); SG&A: $125.2M (+5.8%); Operating Loss: ($102.1M) (+39.7%); Net Loss: ($142.7M) (+24.7%); Loss Per Share: ($1.00) (+28.1%); Non-GAAP Loss Per Share: ($0.93) (+33.1%); Quick Assets: $439.4M (+77.0%).
- 2016 Guidance: R&D Expenses: $130M - 145M; SG&A Expenses: $125M - 140M; Cash for Operations: <$60M.
Thu, Feb. 18, 4:14 PM
Wed, Feb. 17, 5:35 PM
Nov. 30, 2015, 4:38 PM
- Ironwood Pharmaceuticals (NASDAQ:IRWD) and licensee Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY) announce that a Japan-based Phase 3 clinical trial assessing linaclotide in patients with irritable bowel syndrome with constipation (IBS-C) successfully achieved its two co-primary endpoints. The first, the number of responders as measured by the Global Assessment of Relief of IBS Symptoms compared to placebo, was 34% and 18%, respectively (p<0.001). The second, Complete Spontaneous Bowel Movement Overall Responders also favored linaclotide 35% to 19% (p<0.001).
- Astellas, holder of commercialization rights in Japan, intends to file a new drug application with the Ministry of Health, Labour and Welfare in 2016. Under the terms of the companies' 2009 license agreement, the submission will trigger a $15M milestone payment to Ironwood. Regulatory clearance will trigger a second $15M payment.
- CSO and President of R&D Mark Currie, Ph.D., says, "Linaclotide has now met all primary endpoints in all eight of its Phase 3/3b clinical trials, spanning two indications, three doses and multiple countries. Our recent positive Phase 3 data in China and now Japan represent important achievements by Ironwood and our global partners toward bringing linaclotide to appropriate patients around the world, and we continue to innovate with linaclotide as part of our mission to address a broad spectrum of patient needs."
- Previously: Ironwood earns $15M milestone from Astellas (Nov. 20, 2014)
Nov. 30, 2015, 11:58 AM
- A Phase 2 clinical trial assessing Ironwood Pharmaceuticals' (IRWD -0.2%) linaclotide in adults with opioid-induced constipation (OIC) met its primary endpoint. The 254-subject, randomized, double-blind, placebo-controlled study was jointly conducted with a subsidiary of Allergan (AGN -1.9%), the company's co-development and co-commercialization partner in the U.S.
- Linaclotide-treated patients demonstrated a statistically significant improvement from baseline to week 8 in Spontaneous Bowel Movement (SBM) frequency rate for both doses evaluated (145 mcg and 290 mcg) compared to placebo.
- Ironwood and Allergan will make a decision on the advancement of the OIC program after they review the results from the linaclotide colonic release Phase 2b study in adults with IBS-C (irritable bowel syndrome with constipation), expected in H2 2016, and a complete analysis of the commercial opportunities (sounds like Allergan is going to bail). Linaclostide, branded as LINZESS in the U.S. and CONSTELLA in the EU, is currently cleared in the U.S. for the treatment of adults with IBS-C or CIC (chronic ideopathic constipation). LINZESS generated $117.5M in U.S. sales in Q3 (+47% yoy), with Ironwood's share coming in at $39.6M.
Nov. 3, 2015, 4:30 PM
- Ironwood Pharmaceuticals (NASDAQ:IRWD): Q3 EPS of -$0.25 misses by $0.05.
- Revenue of $39.6M (+134.0% Y/Y) misses by $2.16M.
Ironwood Pharmaceuticals, Inc. is an entrepreneurial pharmaceutical company. It discovers, develops and intends to commercialize differentiated medicines that improve patient's lives. Its product candidate is linaclotide, a guanylate cyclase type-C agonist being developed for the treatment of... More
Industry: Medical Laboratories & Research
Country: United States
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